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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02996500




Registration number
NCT02996500
Ethics application status
Date submitted
13/10/2016
Date registered
19/12/2016

Titles & IDs
Public title
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
Scientific title
A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
Secondary ID [1] 0 0
2016-002337-30
Secondary ID [2] 0 0
B7921005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06650833
Treatment: Drugs - Placebo
Treatment: Drugs - Tofacitinib

Experimental: Arm 1: 20 mg QD - PF-06650833 , 20 mg QD

Experimental: Arm 2: 60 mg QD - PF-06650833, 60 mg QD

Experimental: Arm 3: 200 mg QD - Pf-06650833, 200 mg QD

Experimental: Arm 4: 400 mg QD - PF-06650833, 400 mg QD

Placebo comparator: Placebo - Placebo, 0 mg BID

Active comparator: Arm 5: Tofacitinib - Tofacitinib 5 mg BID


Treatment: Drugs: PF-06650833
Investigational

Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: Tofacitinib
Investigational
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in SDAI at Weeks 4 and 8
Timepoint [1] 0 0
Baseline, Weeks 4 and 8
Secondary outcome [2] 0 0
Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks
Timepoint [2] 0 0
Weeks 4, 8 and 12
Secondary outcome [3] 0 0
Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks
Timepoint [3] 0 0
Weeks 4, 8 and 12
Secondary outcome [4] 0 0
Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Timepoint [4] 0 0
Weeks 4, 8 and 12
Secondary outcome [5] 0 0
Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Timepoint [5] 0 0
Weeks 4, 8 and 12
Secondary outcome [6] 0 0
Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Timepoint [6] 0 0
Weeks 4, 8 and 12
Secondary outcome [7] 0 0
Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Timepoint [7] 0 0
Weeks 4, 8 and 12
Secondary outcome [8] 0 0
Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Timepoint [8] 0 0
Weeks 4, 8 and 12
Secondary outcome [9] 0 0
Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Timepoint [9] 0 0
Weeks 4, 8 and 12
Secondary outcome [10] 0 0
Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Timepoint [10] 0 0
Weeks 4, 8 and 12
Secondary outcome [11] 0 0
Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Timepoint [11] 0 0
Weeks 4, 8 and 12
Secondary outcome [12] 0 0
Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks
Timepoint [12] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [13] 0 0
Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks
Timepoint [13] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [14] 0 0
Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks
Timepoint [14] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [15] 0 0
Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks
Timepoint [15] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [16] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 4, 8 and 12 Weeks
Timepoint [16] 0 0
Weeks 4, 8 and 12
Secondary outcome [17] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 4, 8 and 12 Weeks
Timepoint [17] 0 0
Weeks 4, 8 and 12
Secondary outcome [18] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 4, 8 and 12 Weeks
Timepoint [18] 0 0
Weeks 4, 8 and 12
Secondary outcome [19] 0 0
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
Timepoint [19] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [20] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at 4, 8 and 12 Weeks
Timepoint [20] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [21] 0 0
Change From Baseline in the Physician's Global Assessment of Arthritis (PhGA) at 4, 8, and 12 Weeks
Timepoint [21] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [22] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
Timepoint [22] 0 0
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Secondary outcome [23] 0 0
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Timepoint [23] 0 0
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Secondary outcome [24] 0 0
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Timepoint [24] 0 0
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Secondary outcome [25] 0 0
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
Timepoint [25] 0 0
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Secondary outcome [26] 0 0
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Timepoint [26] 0 0
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Secondary outcome [27] 0 0
Change From Baseline in the Patient's Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12
Timepoint [27] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [28] 0 0
Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12
Timepoint [28] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [29] 0 0
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 4, 8, and 12
Timepoint [29] 0 0
Baseline, Weeks 4, 8 and 12
Secondary outcome [30] 0 0
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Timepoint [30] 0 0
Baseline and Week 12
Secondary outcome [31] 0 0
Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12
Timepoint [31] 0 0
Baseline and Week 12
Secondary outcome [32] 0 0
Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12
Timepoint [32] 0 0
Baseline and Week 12
Secondary outcome [33] 0 0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Week 12
Timepoint [33] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
1. Male and female (including WOCBP) subjects between the ages of 18 and 75 years, inclusive.
2. Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA with a Total Score =6/10.
3. The subject has active disease at both Screening and Baseline, as defined by both:

* 6 joints tender or painful on motion, AND
* 6 joints swollen; and fulfills 1 of the following 2 criteria at Screening:
* High sensitivity C reactive protein (hsCRP) >7 mg/L at screening
* Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr;
4. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
5. Subjects must be ACPA positive between screening and randomization.
6. Subjects must have been taking oral MTX for at least 3 months at an adequate dose to determine that the subject had an inadequate response to MTX
7. Up to 50 % of subjects may have received one (and only one) approved TNF-inhibiting biologic agent administered that was inadequately effective and/or not tolerated. The anti-TNF biologic could also have been discontinued due to lack of continued access.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
2. Subjects with any of the following infections or infections history:

1. Any infection requiring treatment within 2 weeks prior to screening (Visit 1).
2. Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days, or as otherwise judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months.
3. Infected joint prosthesis at any time with the prosthesis still in situ.
4. Recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
5. Subjects will be screened for HIV. Subjects who test positive for HIV will be excluded from the study.
6. Subjects will be screened for hepatitis B virus infection and will be excluded if positive for hepatitis B surface antigen (HBsAg). Subjects with HBsAg negative testing but who test positive for hepatitis B core antibody (HBcAb) must have further testing for hepatitis B surface antibody (HBsAb). If HBsAb is negative, the subject will be excluded from the study.
7. Subjects with clinically significant active hepatic disease or hepatic impairment by laboratory assessment.
8. Subjects will be screened for hepatitis C virus (HCV Ab). Subjects with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA). Only subjects with negative HCV Ab or HCV RNA will be allowed to enroll in the study.
3. Evidence of active or latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB)
4. Pre-existing chronic autoimmune disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2018
Sample size
Target
Accrual to date
Final
269
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Genesis Research Services - Broadmeadow
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Kanton Sarajevo
Country [10] 0 0
Bosnia and Herzegovina
State/province [10] 0 0
Republika Srpska
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Plovdiv
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Sofia
Country [13] 0 0
Croatia
State/province [13] 0 0
GRAD Zagreb
Country [14] 0 0
Croatia
State/province [14] 0 0
Zagreb
Country [15] 0 0
Czechia
State/province [15] 0 0
Ostrava
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha
Country [17] 0 0
Czechia
State/province [17] 0 0
Uherske Hradiste
Country [18] 0 0
Georgia
State/province [18] 0 0
Tbilisi
Country [19] 0 0
Georgia
State/province [19] 0 0
Telavi
Country [20] 0 0
Germany
State/province [20] 0 0
Puettlingen
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Hungary
State/province [22] 0 0
Kistarcsa
Country [23] 0 0
Hungary
State/province [23] 0 0
Miskolc
Country [24] 0 0
Hungary
State/province [24] 0 0
Szeged
Country [25] 0 0
Hungary
State/province [25] 0 0
Szentes
Country [26] 0 0
Hungary
State/province [26] 0 0
Veszprem
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Mexico
State/province [28] 0 0
Morelos
Country [29] 0 0
Mexico
State/province [29] 0 0
Yucatan
Country [30] 0 0
Mexico
State/province [30] 0 0
San Luis Potosí
Country [31] 0 0
Poland
State/province [31] 0 0
Bytom
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Gdynia
Country [34] 0 0
Poland
State/province [34] 0 0
Grodzisk Mazowiecki
Country [35] 0 0
Poland
State/province [35] 0 0
Katowice
Country [36] 0 0
Poland
State/province [36] 0 0
Poznan
Country [37] 0 0
Poland
State/province [37] 0 0
Warszawa
Country [38] 0 0
Poland
State/province [38] 0 0
Wroclaw
Country [39] 0 0
Romania
State/province [39] 0 0
Bucuresti
Country [40] 0 0
Romania
State/province [40] 0 0
Iasi
Country [41] 0 0
Romania
State/province [41] 0 0
Tirgu Mures
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Kazan
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Ryazan
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Saint-Petersburg
Country [46] 0 0
Russian Federation
State/province [46] 0 0
St. Petersburg
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Vladimir
Country [48] 0 0
Serbia
State/province [48] 0 0
Belgrade
Country [49] 0 0
Serbia
State/province [49] 0 0
Niska Banja
Country [50] 0 0
Serbia
State/province [50] 0 0
Novi Sad
Country [51] 0 0
Slovakia
State/province [51] 0 0
Trenciansky Kraj.
Country [52] 0 0
Slovakia
State/province [52] 0 0
Dunajska Streda
Country [53] 0 0
Slovakia
State/province [53] 0 0
Kosice-Saca
Country [54] 0 0
Slovakia
State/province [54] 0 0
Považská Bystrica
Country [55] 0 0
Slovakia
State/province [55] 0 0
Rimavska Sobota
Country [56] 0 0
Slovakia
State/province [56] 0 0
Zilina
Country [57] 0 0
Spain
State/province [57] 0 0
A Coruna
Country [58] 0 0
Spain
State/province [58] 0 0
A Coruña
Country [59] 0 0
Spain
State/province [59] 0 0
Vizcaya
Country [60] 0 0
Spain
State/province [60] 0 0
Sevilla
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taichung
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Ukraine
State/province [63] 0 0
Chernihiv
Country [64] 0 0
Ukraine
State/province [64] 0 0
Kharkiv
Country [65] 0 0
Ukraine
State/province [65] 0 0
Kyiv
Country [66] 0 0
Ukraine
State/province [66] 0 0
Poltava
Country [67] 0 0
Ukraine
State/province [67] 0 0
Ternopil
Country [68] 0 0
Ukraine
State/province [68] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02996500