Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01142726
Registration number
NCT01142726
Ethics application status
Date submitted
3/06/2010
Date registered
11/06/2010
Date last updated
14/01/2016
Titles & IDs
Public title
Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
Query!
Scientific title
A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA
Query!
Secondary ID [1]
0
0
2010-018674-20
Query!
Secondary ID [2]
0
0
IM101-226
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Methotrexate
Treatment: Drugs - Abatacept placebo
Treatment: Drugs - Methotrexate placebo
Active Comparator: Abatacept, 125 mg, plus methotrexate, 2.5 mg - Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
Active Comparator: Methotrexate, 2.5 mg, plus abatacept placebo - Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
Active Comparator: Abatacept, 125 mg, plus methotrexate placebo - Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
Treatment: Drugs: Abatacept
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Treatment: Drugs: Methotrexate
Tablets, oral, 2.5 mg, once weekly, 12 months
Treatment: Drugs: Abatacept placebo
Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months
Treatment: Drugs: Methotrexate placebo
Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
Query!
Assessment method [1]
0
0
DAS28-CRP remission defined as <2.6; TP=treatment phase; WP=withdrawal phase. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Query!
Timepoint [1]
0
0
Randomization to Months 12 and 18
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
Query!
Assessment method [1]
0
0
TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Query!
Timepoint [1]
0
0
Randomization to Months 12 and 18
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time - Intent to Treat Population
Query!
Assessment method [2]
0
0
TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Query!
Timepoint [2]
0
0
Randomization to Month 24
Query!
Secondary outcome [3]
0
0
Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18
Query!
Assessment method [3]
0
0
TP=treatment period; WP=withdrawal period. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Query!
Timepoint [3]
0
0
Baseline to Month 18
Query!
Secondary outcome [4]
0
0
Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18
Query!
Assessment method [4]
0
0
TP=treatment period; WP=withdrawal period. SDAI-defined remission= =3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity.
Query!
Timepoint [4]
0
0
Randomization to Month 18
Query!
Secondary outcome [5]
0
0
Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time
Query!
Assessment method [5]
0
0
TP=treatment period; WP=withdrawal period. The SDAI is the simple linear sum of 5 outcome parameters: swollen joint count (SJC) and tender joint count (TJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SJC is assessed and recorded at each visit, with no swelling=0, swelling=1 (higher score indicates greater swelling). TJC is assessed at each visit through identification of joints that are painful under pressure or to passive motion, with no tenderness=0, tenderness=1 (higher score indicates greater affection due to disease activity)..
Query!
Timepoint [5]
0
0
Randomization to Month 18
Query!
Secondary outcome [6]
0
0
Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time
Query!
Assessment method [6]
0
0
HAQ response defined as a reduction of at least 0.3 units from baseline in score on the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.
Query!
Timepoint [6]
0
0
Randomization to Month 24
Query!
Secondary outcome [7]
0
0
Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Over Time
Query!
Assessment method [7]
0
0
The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.
Query!
Timepoint [7]
0
0
Randomization to Month 18
Query!
Secondary outcome [8]
0
0
Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores of Short Form-36 (SF-36)
Query!
Assessment method [8]
0
0
TP=treatment period; WP=withdrawal period. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Query!
Timepoint [8]
0
0
Randomization to Months 6, 12, and 18
Query!
Secondary outcome [9]
0
0
Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)
Query!
Assessment method [9]
0
0
TP=treatment period; WP=withdrawal period. Change from Baseline=Postbaseline-baseline value. MRI was used to assess joint damage progression at Months 6, 12, and 18. If >20% of joints with a missing score for a parameter (erosion, osteitis, and synovitis), the MRI score of each parameter was considered missing. If =20% of joints had a missing score for a parameter, the MRI score for that parameter from the missing joints was carried forward from the previous MRI assessment, or carried backward from the next MRI assessment, if missing score occurred at baseline. MRI total score ranged from 0 (best outcome) to 4 (worst outcome). A gadolinium-enhanced MRI of the dominant hand-wrist was performed on all randomized patients at 5 points. The hand/wrist assessed to have more synovitis was selected initially and used for all subsequent evaluations. The MRI examination was standardized to ensure sufficient image quality for the evaluation of radiographic progression of rheumatoid arthritis.
Query!
Timepoint [9]
0
0
Randomization to Month 18
Query!
Secondary outcome [10]
0
0
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period
Query!
Assessment method [10]
0
0
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Query!
Timepoint [10]
0
0
Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period
Query!
Secondary outcome [11]
0
0
Adverse Events (AEs) of Interest During the Treatment Period
Query!
Assessment method [11]
0
0
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. AEs of special interest are events potentially associated with the drug or disease under study.
Query!
Timepoint [11]
0
0
Day 1 to 56 days following last dosing day (Day 365)
Query!
Secondary outcome [12]
0
0
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality During Treatment Period
Query!
Assessment method [12]
0
0
Lower limit of normal (LLN); Upper limit of normal (ULN); Pretreatment (preRX). Criteria for marked abnormality: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.
Query!
Timepoint [12]
0
0
Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)
Query!
Secondary outcome [13]
0
0
Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time During Withdrawal Period- Treated Participants in Remission at Month 12
Query!
Assessment method [13]
0
0
WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.). Percentage= number of participants with remission divided by number of participants who were analyzed (all treated participants who were in remission at end of treatment period and entered the Withdrawal Period)
Query!
Timepoint [13]
0
0
End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)
Query!
Secondary outcome [14]
0
0
Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) Over Time in Treatment Period and Withdrawal Period
Query!
Assessment method [14]
0
0
TP=treatment period; WP=withdrawal period. SDAI-defined remission= =3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity. Percent=number with remission/number evaluated (ITT)
Query!
Timepoint [14]
0
0
Randomization to Month 24
Query!
Secondary outcome [15]
0
0
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) and Discontinuations Due to AEs During the Full Study (All Periods)
Query!
Assessment method [15]
0
0
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Includes data up to last active dose date +56 days if the participant discontinued the Treatment Period or did not enter the Withdrawal Period, up to the day of discontinuation in the Withdrawal Period for participants discontinuing the Withdrawal Period without entering the Re-exposure Period (RP), up to Day 729 visit (Month 24) for participants who complete the Withdrawal Period, and up to 56 days post last active dose in Re-exposure Period for participants entering the Re-exposure Period.
Query!
Timepoint [15]
0
0
Day 1 to 56 days post last dose in the study, up to Month 30
Query!
Secondary outcome [16]
0
0
Adverse Events (AEs) of Interest During the Withdrawal Period
Query!
Assessment method [16]
0
0
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes events with an onset date on or after 57 days post last dosing day (active abatacept or active MTX whichever is the later) in the Treatment Period and up to end of Withdrawal Period. Treatment groups represent treatment received during the Treatment Period.
Query!
Timepoint [16]
0
0
Last dose in TP + 57 days, up to Month 24
Query!
Secondary outcome [17]
0
0
Adverse Events (AEs) of Interest During the Re-exposure Period
Query!
Assessment method [17]
0
0
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.
Query!
Timepoint [17]
0
0
First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days
Query!
Secondary outcome [18]
0
0
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Withdrawal Period
Query!
Assessment method [18]
0
0
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase (GGT) (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.
Query!
Timepoint [18]
0
0
Last dose in TP + 57 days, up to Month 24
Query!
Secondary outcome [19]
0
0
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Re-exposure Period
Query!
Assessment method [19]
0
0
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.
Query!
Timepoint [19]
0
0
Start of re-exposure period to 56 days post last dose, up to Month 30
Query!
Eligibility
Key inclusion criteria
Key
- Presence of active clinical synovitis in at least 2 joints, 1 of which must have been
a small joint, for a minimum of 8 weeks prior to screening
- Onset of persistent symptoms = 2 years prior to screening
- Positive test result for anticyclic citrullinated peptides 2
- Methotrexate naive or with minimum exposure to methotrexate, defined as no more than
10 mg/week for =4 weeks and no methotrexate dose for 1 month prior to screening visit
- Biologic naive, including no treatment with an investigational biologic prior to
screening
- Disease Activity Score 28 based on C-reactive protein score =3.2 at screening
- Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or
sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
- If receiving oral corticosteroids, on a stable low dose (= 10 mg/day prednisone
equivalent) for at least 4 weeks
- Able to undergo magnetic resonance imaging
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)
- Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within
4 weeks prior to randomization
- Scheduled for or anticipating joint replacement surgery
- Presence of concomitant illness likely to require systemic glucocorticosteroid therapy
during the study, in the opinion of the investigator
- History of malignancy in the last 5 years
- Any serious bacterial infection within the last 3 months not treated or resolved with
antibiotics, or any chronic or recurrent bacterial infection
- At risk for tuberculosis
- Evidence of active or latent bacterial or viral infection at the time of potential
enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus
that resolved less than 2 months prior to enrollment
Query!
Study design
Purpose of the study
Treatment
Query!
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
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
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
1/12/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
511
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Cairns
Query!
Recruitment hospital [2]
0
0
Local Institution - Maroochydore
Query!
Recruitment hospital [3]
0
0
Local Institution - Woodville
Query!
Recruitment hospital [4]
0
0
Local Institution - Heidelberg
Query!
Recruitment hospital [5]
0
0
Local Institution - Malvern
Query!
Recruitment hospital [6]
0
0
Local Institution - Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
4870 - Cairns
Query!
Recruitment postcode(s) [2]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [4]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [6]
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
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Idaho
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nebraska
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Wisconsin
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Bruxelles
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Kortrijk
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Merksem
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Alberta
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Quebec
Query!
Country [19]
0
0
Denmark
Query!
State/province [19]
0
0
Hjorring
Query!
Country [20]
0
0
Finland
Query!
State/province [20]
0
0
Helsinki
Query!
Country [21]
0
0
Finland
Query!
State/province [21]
0
0
Tampere
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Chambray Les Tours
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Montpellier
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Paris Cedex 14
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Poitiers
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Berlin
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Hildesheim
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Muenchen
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Ancona
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Siena
Query!
Country [31]
0
0
Korea, Republic of
Query!
State/province [31]
0
0
Daegu
Query!
Country [32]
0
0
Korea, Republic of
Query!
State/province [32]
0
0
Daejeon
Query!
Country [33]
0
0
Korea, Republic of
Query!
State/province [33]
0
0
Seoul
Query!
Country [34]
0
0
Mexico
Query!
State/province [34]
0
0
Estado De Mexico
Query!
Country [35]
0
0
Mexico
Query!
State/province [35]
0
0
Jalisco
Query!
Country [36]
0
0
Mexico
Query!
State/province [36]
0
0
Nuevo Leon
Query!
Country [37]
0
0
Mexico
Query!
State/province [37]
0
0
Yucatan
Query!
Country [38]
0
0
Mexico
Query!
State/province [38]
0
0
Chihuahua
Query!
Country [39]
0
0
Mexico
Query!
State/province [39]
0
0
Queretaro
Query!
Country [40]
0
0
Mexico
Query!
State/province [40]
0
0
San Luis Potosi
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Lublin
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Poznan
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Torun
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Warszawa
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Wroc#aw
Query!
Country [46]
0
0
Russian Federation
Query!
State/province [46]
0
0
Moscow
Query!
Country [47]
0
0
Russian Federation
Query!
State/province [47]
0
0
Tver
Query!
Country [48]
0
0
South Africa
Query!
State/province [48]
0
0
Gauteng
Query!
Country [49]
0
0
South Africa
Query!
State/province [49]
0
0
Kwa Zulu Natal
Query!
Country [50]
0
0
South Africa
Query!
State/province [50]
0
0
Western Cape
Query!
Country [51]
0
0
Sweden
Query!
State/province [51]
0
0
Goteborg
Query!
Country [52]
0
0
Sweden
Query!
State/province [52]
0
0
Linkoping
Query!
Country [53]
0
0
Sweden
Query!
State/province [53]
0
0
Malmo
Query!
Country [54]
0
0
Sweden
Query!
State/province [54]
0
0
Stockholm
Query!
Country [55]
0
0
Sweden
Query!
State/province [55]
0
0
Uppsala
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary purpose of the protocol is to demonstrate the ability of abatacept plus
methotrexate to induce remission in patients with very early rheumatoid arthritis after 12
months of treatment and to maintain remission following 6 months of drug withdrawal.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01142726
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01142726
Download to PDF