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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02092467
Registration number
NCT02092467
Ethics application status
Date submitted
3/03/2014
Date registered
20/03/2014
Date last updated
17/08/2021
Titles & IDs
Public title
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
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Scientific title
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
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Secondary ID [1]
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2013-003177-99
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Secondary ID [2]
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A3921133
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tofacitinib
Treatment: Drugs - tofacitinib
Other interventions - adalimumab
Other interventions - etanercept
Experimental: Treatment Arm 1 -
Experimental: Treatment Arm 2 -
Active Comparator: Treatment Arm 3 - TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
Treatment: Drugs: tofacitinib
Oral tablet, 5 mg BID
Treatment: Drugs: tofacitinib
Oral tablet, 10 mg BID
Other interventions: adalimumab
Pre-filled syringe, 40 mg subcutaneous injection, every other week
Other interventions: etanercept
Pre-filled syringe, 50 mg subcutaneous injection, every week
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
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Assessment method [1]
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Incidence rate (number of participants with event per 100 participant year [PY]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
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Timepoint [1]
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Baseline up to last contact date (maximum up to 72 months)
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Primary outcome [2]
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Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)
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Assessment method [2]
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MACE included the cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke of any classification, including reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
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Timepoint [2]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [1]
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Incidence Rate of Non-fatal Stroke
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Assessment method [1]
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Non-fatal stroke included reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
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Timepoint [1]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [2]
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Incidence Rate of Non-fatal Myocardial Infarction
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Assessment method [2]
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Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
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Timepoint [2]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [3]
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Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis
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Assessment method [3]
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Opportunistic infections (OI) were reviewed and adjudicated by the opportunistic infection review committee (OIRC). Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
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Timepoint [3]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [4]
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Incidence Rate of Adjudicated Hepatic Events
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Assessment method [4]
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Hepatic events (adjudicated) included drug-induced liver injury (DILI) - probable, highly likely and definite, DILI - listed separately, DILI - cases meeting classification and severity, participants with elevations of transaminase levels greater than (>) 1* upper limit of normal (ULN), greater than or equal to (>=) 3*ULN, >=5*ULN (based on laboratory values). Incidence rate was the total number of participants with admissible events divided by total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was minimum of The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.
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Timepoint [4]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [5]
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Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)
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Assessment method [5]
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Cardiovascular events (adjudicated) were death (coronary and non-coronary), MI, all coronary revascularization, unstable angina, new ischemic heart disease, stroke (fatal and non-fatal), transient ischemic attack (TIA), congestive heart failure (CHF), peripheral arterial vascular disease (PAVD), deep vein thrombosis, pulmonary embolism, arterial embolism, arterial thrombosis. Incidence rate was total number of participants with admissible events divided by total (for all qualifying participants) time at risk for cohort/treatment group of interest. Risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.
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Timepoint [5]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [6]
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [6]
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AE was any untoward medical occurrence post treatment; event need not necessarily had causal relationship with treatment or usage. SAE: any untoward medical occurrence at any dose: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly. TEAE: event that occurred for first time during effective duration of treatment and not seen prior to start of treatment or event seen prior to start of treatment but increase in severity during treatment. Risk period (RP) for AE: minimum of last contact date or last study treatment dose date+28 days. RP for SAEs: last contact date. Last contact date was maximum: AE start, AE stop, last study visit, withdrawal and telephone contact. In case of death, last contact was death date. First events counted within RP. Participant did not have event or had event outside risk period were censored at end of RP.
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Timepoint [6]
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AEs: Baseline up to minimum of last contact date or last study treatment dose date+28 days (maximum up to 72 months); SAEs: Baseline up to minimum of last contact date (maximum up to 72 months)
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Secondary outcome [7]
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Number of Participants With Clinically Significant Abnormal Laboratory Parameters
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Assessment method [7]
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Clinically significant laboratory abnormalities: Hematology: hemoglobin, hematocrit, erythrocytes with primary criteria as less than [<] 0.8* lower limit of normal [LLN]), platelets (<0.5* LLN; >1.75* ULN), leukocytes (<0.6*LLN; >1.5*ULN), lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes (<0.8*LLN; >1.2*ULN), eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes (>1.2*ULN); urinalysis: urine glucose, urine protein, urine hemoglobin, and leukocyte esterase (>=1); chemistry: bilirubin, indirect bilirubin (>1.5*ULN) aspartate aminotransferase, alanine aminotransferase (>3.0*ULN), creatinine, triglycerides, cholesterol (>1.3*ULN) and HDL cholesterol (<0.8*LLN). Risk period (RP) was minimum of last contact date or last study treatment dose date+28 days. Last contact date was (date of death or maximum of dates: AE start, AE stop, last study visit, withdrawal, telephone contact). Participants without event or event outside RP were censored at end of RP.
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Timepoint [7]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [8]
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Incidence Rate of Adjudicated All-Cause Deaths
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Assessment method [8]
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All-cause death was defined as the death due to any cause during the course of study. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Incidence rate of all-cause deaths (adjudicated by Adjudication Committee) was reported in this outcome measure. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
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Timepoint [8]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [9]
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Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication
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Assessment method [9]
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Number of participants who permanent or temporary discontinued study medication due to any AE, treatment related AEs, Coronavirus disease 2019 (COVID 19) related AEs, and herpes zoster were reported. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
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Timepoint [9]
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Baseline up to last contact date (maximum up to 72 months)
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Secondary outcome [10]
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Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Assessment method [10]
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DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (milligrams per liter [mg/L]) and patient's global assessment of disease activity (PtGA) on a 100 mm Visual Analog Scale (VAS) (scores ranging from 0 millimeter [mm] [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root.
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Timepoint [10]
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Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Secondary outcome [11]
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Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Assessment method [11]
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SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and physician's global assessment of health (PhyGA) both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
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Timepoint [11]
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Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Secondary outcome [12]
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Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Assessment method [12]
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CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
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Timepoint [12]
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Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Secondary outcome [13]
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Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria
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Assessment method [13]
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ACR-EULAR Boolean-based definition of remission participant must satisfy all of the following: TJC28 <=1, SJC28 <=1, CRP <=10 mg/L, PtGA on a 0-100 mm scale, higher scores indicate greater affection due to disease activity.
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Timepoint [13]
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Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [14]
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Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3
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Assessment method [14]
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SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
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Timepoint [14]
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Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [15]
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Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8
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Assessment method [15]
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CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
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Timepoint [15]
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Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [16]
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Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11
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Assessment method [16]
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SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
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Timepoint [16]
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Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [17]
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Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10
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Assessment method [17]
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CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
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Timepoint [17]
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Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [18]
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Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2
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Assessment method [18]
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DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96.
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Timepoint [18]
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Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [19]
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Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
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Assessment method [19]
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ACR20 response is a >= 20% improvement in TJC (28) and SJC (28) and >=20% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
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Timepoint [19]
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Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [20]
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Number of Participants With an American College of Rheumatology 50% (ACR50) Response
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Assessment method [20]
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ACR50 response is a >= 50% improvement in TJC (28) and SJC (28) and >=50% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
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Timepoint [20]
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0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [21]
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Number of Participants With an American College of Rheumatology 70% (ACR70) Response
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Assessment method [21]
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ACR70 response is a >= 70% improvement in TJC (28) and SJC (28) and >=70% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
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Timepoint [21]
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0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
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Secondary outcome [22]
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Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Assessment method [22]
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HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
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Timepoint [22]
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Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
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Eligibility
Key inclusion criteria
- Moderate to severe rheumatoid arthritis
- Taking methotrexate without adequate control of symptoms
- Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure,
high cholesterol levels, diabetes mellitus, history of heart attack, family history of
coronary heart disease, extra-articular RA disease)
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current or recent infection
- Clinically significant laboratory abnormalities
- Pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/03/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
22/07/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
4372
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [2]
0
0
St. Vincent's Hospital (Melbourne) - Fitzroy
Query!
Recruitment hospital [3]
0
0
Austin Health - Repatriation Hospital - Heidelberg West
Query!
Recruitment hospital [4]
0
0
Austin Repatriation Hospital - Heidelberg
Query!
Recruitment hospital [5]
0
0
RK Will Pty Ltd - Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [2]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
3081 - Heidelberg West
Query!
Recruitment postcode(s) [4]
0
0
3081 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
6100 - Victoria Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Minnesota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Missouri
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Montana
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Nebraska
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Nevada
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New Hampshire
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
New Jersey
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New York
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
North Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
North Dakota
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Ohio
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Oklahoma
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Pennsylvania
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
South Carolina
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Tennessee
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Texas
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Virginia
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Wisconsin
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Caba
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Santa FE
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Tucuman
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Buenos Aires
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Cordoba
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
Rosario
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
San Isidro
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
San Juan
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
BA
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Espírito Santo
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
MG
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Minas Gerais
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
PR
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
RJ
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
RS
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
SAO Paulo
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
SP
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
Rio Grande De Sul
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Sao Paulo
Query!
Country [54]
0
0
Bulgaria
Query!
State/province [54]
0
0
Pleven
Query!
Country [55]
0
0
Bulgaria
Query!
State/province [55]
0
0
Plovdiv
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Ruse
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Sofia
Query!
Country [58]
0
0
Bulgaria
Query!
State/province [58]
0
0
Varna
Query!
Country [59]
0
0
Canada
Query!
State/province [59]
0
0
Alberta
Query!
Country [60]
0
0
Canada
Query!
State/province [60]
0
0
British Columbia
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
Ontario
Query!
Country [62]
0
0
Canada
Query!
State/province [62]
0
0
Quebec
Query!
Country [63]
0
0
Chile
Query!
State/province [63]
0
0
Metropolitana
Query!
Country [64]
0
0
Chile
Query!
State/province [64]
0
0
Region DE LA Araucania
Query!
Country [65]
0
0
Chile
Query!
State/province [65]
0
0
Region Metropolitana
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Guangdong
Query!
Country [67]
0
0
Colombia
Query!
State/province [67]
0
0
Antioquia
Query!
Country [68]
0
0
Colombia
Query!
State/province [68]
0
0
Cundinamarca
Query!
Country [69]
0
0
Colombia
Query!
State/province [69]
0
0
Santander
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Czech Republic
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Brno - Zidenice
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Brno
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Ostrava
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Praha 2
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Praha 4
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Zlin
Query!
Country [77]
0
0
Finland
Query!
State/province [77]
0
0
Helsinki
Query!
Country [78]
0
0
Finland
Query!
State/province [78]
0
0
Hyvinkaa
Query!
Country [79]
0
0
Hong Kong
Query!
State/province [79]
0
0
HKG
Query!
Country [80]
0
0
Hong Kong
Query!
State/province [80]
0
0
Hong Kong
Query!
Country [81]
0
0
Hong Kong
Query!
State/province [81]
0
0
Shatin
Query!
Country [82]
0
0
Israel
Query!
State/province [82]
0
0
Ashkelon
Query!
Country [83]
0
0
Israel
Query!
State/province [83]
0
0
Beer Yaacov
Query!
Country [84]
0
0
Israel
Query!
State/province [84]
0
0
Haifa
Query!
Country [85]
0
0
Israel
Query!
State/province [85]
0
0
Jerusalem
Query!
Country [86]
0
0
Israel
Query!
State/province [86]
0
0
Kfar Saba
Query!
Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Petah Tikva
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Tel Aviv
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
Tel-Hashomer
Query!
Country [90]
0
0
Jordan
Query!
State/province [90]
0
0
Amman
Query!
Country [91]
0
0
Jordan
Query!
State/province [91]
0
0
Irbid
Query!
Country [92]
0
0
Lebanon
Query!
State/province [92]
0
0
Beirut
Query!
Country [93]
0
0
Lebanon
Query!
State/province [93]
0
0
Lebanon
Query!
Country [94]
0
0
Malaysia
Query!
State/province [94]
0
0
Perak
Query!
Country [95]
0
0
Malaysia
Query!
State/province [95]
0
0
Sarawak
Query!
Country [96]
0
0
Malaysia
Query!
State/province [96]
0
0
Selangor
Query!
Country [97]
0
0
Mexico
Query!
State/province [97]
0
0
Coahuila
Query!
Country [98]
0
0
Mexico
Query!
State/province [98]
0
0
Distrito Federal
Query!
Country [99]
0
0
Mexico
Query!
State/province [99]
0
0
Jalisco
Query!
Country [100]
0
0
Mexico
Query!
State/province [100]
0
0
Michoacan
Query!
Country [101]
0
0
Mexico
Query!
State/province [101]
0
0
Sinaloa
Query!
Country [102]
0
0
Mexico
Query!
State/province [102]
0
0
Yucatan
Query!
Country [103]
0
0
Mexico
Query!
State/province [103]
0
0
Chihuahua
Query!
Country [104]
0
0
Mexico
Query!
State/province [104]
0
0
Ciudad de Mexico
Query!
Country [105]
0
0
Mexico
Query!
State/province [105]
0
0
San Luis Potosi
Query!
Country [106]
0
0
Netherlands
Query!
State/province [106]
0
0
Leeuwarden
Query!
Country [107]
0
0
Netherlands
Query!
State/province [107]
0
0
Utrecht
Query!
Country [108]
0
0
New Zealand
Query!
State/province [108]
0
0
Auckland
Query!
Country [109]
0
0
New Zealand
Query!
State/province [109]
0
0
Hamilton
Query!
Country [110]
0
0
New Zealand
Query!
State/province [110]
0
0
Timaru
Query!
Country [111]
0
0
New Zealand
Query!
State/province [111]
0
0
Wellington
Query!
Country [112]
0
0
Peru
Query!
State/province [112]
0
0
LA Libertad
Query!
Country [113]
0
0
Peru
Query!
State/province [113]
0
0
Arequipa
Query!
Country [114]
0
0
Peru
Query!
State/province [114]
0
0
Lima
Query!
Country [115]
0
0
Poland
Query!
State/province [115]
0
0
Mazowieckie
Query!
Country [116]
0
0
Poland
Query!
State/province [116]
0
0
Podlaskie
Query!
Country [117]
0
0
Poland
Query!
State/province [117]
0
0
Bydgoszcz
Query!
Country [118]
0
0
Poland
Query!
State/province [118]
0
0
Elblag
Query!
Country [119]
0
0
Poland
Query!
State/province [119]
0
0
Gdynia
Query!
Country [120]
0
0
Poland
Query!
State/province [120]
0
0
Katowice
Query!
Country [121]
0
0
Poland
Query!
State/province [121]
0
0
Lublin
Query!
Country [122]
0
0
Poland
Query!
State/province [122]
0
0
Olsztyn
Query!
Country [123]
0
0
Poland
Query!
State/province [123]
0
0
Poznan
Query!
Country [124]
0
0
Poland
Query!
State/province [124]
0
0
Sopot
Query!
Country [125]
0
0
Poland
Query!
State/province [125]
0
0
Staszow
Query!
Country [126]
0
0
Poland
Query!
State/province [126]
0
0
Torun
Query!
Country [127]
0
0
Poland
Query!
State/province [127]
0
0
Warsaw
Query!
Country [128]
0
0
Poland
Query!
State/province [128]
0
0
Warszawa
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Wroclaw
Query!
Country [130]
0
0
Puerto Rico
Query!
State/province [130]
0
0
Ponce
Query!
Country [131]
0
0
Puerto Rico
Query!
State/province [131]
0
0
San Juan
Query!
Country [132]
0
0
Russian Federation
Query!
State/province [132]
0
0
St.petersburg
Query!
Country [133]
0
0
Russian Federation
Query!
State/province [133]
0
0
Moscow
Query!
Country [134]
0
0
Russian Federation
Query!
State/province [134]
0
0
Nizhniy Novgorod
Query!
Country [135]
0
0
Russian Federation
Query!
State/province [135]
0
0
Novosibirsk
Query!
Country [136]
0
0
Russian Federation
Query!
State/province [136]
0
0
Petrozavodsk
Query!
Country [137]
0
0
Russian Federation
Query!
State/province [137]
0
0
Smolensk
Query!
Country [138]
0
0
Russian Federation
Query!
State/province [138]
0
0
St. Petersburg
Query!
Country [139]
0
0
Russian Federation
Query!
State/province [139]
0
0
Yekaterinburg
Query!
Country [140]
0
0
Slovakia
Query!
State/province [140]
0
0
Bratislava - Petrzalka
Query!
Country [141]
0
0
Slovakia
Query!
State/province [141]
0
0
Bratislava
Query!
Country [142]
0
0
Slovakia
Query!
State/province [142]
0
0
Dunajska Streda
Query!
Country [143]
0
0
Slovakia
Query!
State/province [143]
0
0
Nove Zamky
Query!
Country [144]
0
0
Slovakia
Query!
State/province [144]
0
0
Partizanske
Query!
Country [145]
0
0
Slovakia
Query!
State/province [145]
0
0
Rimavska Sobota
Query!
Country [146]
0
0
Slovakia
Query!
State/province [146]
0
0
Trnava
Query!
Country [147]
0
0
South Africa
Query!
State/province [147]
0
0
Eastern CAPE
Query!
Country [148]
0
0
South Africa
Query!
State/province [148]
0
0
Gauteng
Query!
Country [149]
0
0
South Africa
Query!
State/province [149]
0
0
Kwa-zulu Natal
Query!
Country [150]
0
0
South Africa
Query!
State/province [150]
0
0
Western CAPE
Query!
Country [151]
0
0
South Africa
Query!
State/province [151]
0
0
Stellenbosch
Query!
Country [152]
0
0
Spain
Query!
State/province [152]
0
0
Badajoz
Query!
Country [153]
0
0
Spain
Query!
State/province [153]
0
0
Cantabria
Query!
Country [154]
0
0
Spain
Query!
State/province [154]
0
0
LA Coruna
Query!
Country [155]
0
0
Spain
Query!
State/province [155]
0
0
Vizcaya
Query!
Country [156]
0
0
Spain
Query!
State/province [156]
0
0
Barcelona
Query!
Country [157]
0
0
Spain
Query!
State/province [157]
0
0
Madrid
Query!
Country [158]
0
0
Spain
Query!
State/province [158]
0
0
Malaga
Query!
Country [159]
0
0
Spain
Query!
State/province [159]
0
0
Sevilla
Query!
Country [160]
0
0
Taiwan
Query!
State/province [160]
0
0
Taiwan (r.o.c)
Query!
Country [161]
0
0
Taiwan
Query!
State/province [161]
0
0
Changhua City
Query!
Country [162]
0
0
Taiwan
Query!
State/province [162]
0
0
Chia-Yi
Query!
Country [163]
0
0
Taiwan
Query!
State/province [163]
0
0
Taichung City
Query!
Country [164]
0
0
Taiwan
Query!
State/province [164]
0
0
Tainan
Query!
Country [165]
0
0
Taiwan
Query!
State/province [165]
0
0
Taipei
Query!
Country [166]
0
0
Taiwan
Query!
State/province [166]
0
0
Taoyuan City
Query!
Country [167]
0
0
Thailand
Query!
State/province [167]
0
0
Bangkok
Query!
Country [168]
0
0
Thailand
Query!
State/province [168]
0
0
Chiang Mai
Query!
Country [169]
0
0
Thailand
Query!
State/province [169]
0
0
Songkhla
Query!
Country [170]
0
0
Turkey
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State/province [170]
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Ankara
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Country [171]
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Turkey
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State/province [171]
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Aydin
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Country [172]
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Turkey
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State/province [172]
0
0
Gaziantep
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Country [173]
0
0
Turkey
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State/province [173]
0
0
Istanbul
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Country [174]
0
0
Turkey
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State/province [174]
0
0
Izmir
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Country [175]
0
0
Turkey
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State/province [175]
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0
Kocaeli
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Country [176]
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0
Turkey
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State/province [176]
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0
Samsun
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Country [177]
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0
Turkey
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State/province [177]
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0
Sivas
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Country [178]
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United Kingdom
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State/province [178]
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0
Dorset
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Country [179]
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United Kingdom
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State/province [179]
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0
Essex
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Country [180]
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0
United Kingdom
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State/province [180]
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0
Cannock
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Country [181]
0
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United Kingdom
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State/province [181]
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0
Liverpool
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Country [182]
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United Kingdom
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State/province [182]
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0
Newcastle Upon Tyne
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Country [183]
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0
United Kingdom
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State/province [183]
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0
North Shields
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Country [184]
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United Kingdom
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State/province [184]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This post-marketing study is designed to compare the safety of tofacitinib versus TNF
inhibitor with respect to major cardiovascular adverse events and malignancies, excluding
non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety
events, including non-melanoma skin cancers, hepatic events, infections, and efficacy
parameters will be collected and evaluated in the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02092467
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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0
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Phone
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0
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Fax
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Email
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Contact person for public queries
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02092467
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