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Trial record 1 of 1 for:    NCT02831855
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Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02831855
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 11, 2016
First Posted Date  ICMJE July 13, 2016
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE September 1, 2016
Actual Primary Completion Date November 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
Change in DAS28-4 (ESR) score from randomization (at week 24) to the end of double-blind MTX withdrawal phase (at week 48) [ Time Frame: week 48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02831855 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Change in the DAS28-4(ESR) from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the DAS28-4 (CRP) from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the CDAI from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in SDAI from week 24 to week 48 [ Time Frame: week 48 ]
  • change in the DAS28-4 (CRP) from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the CDAI from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the SDAI from week 24 to week 36 [ Time Frame: week 36 ]
  • LDA as assessed by DAS28-4(ESR) <=3.2 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by DAS28-4(CRP) <=3.2 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by CDAI<=10 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by SDAI<=11 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by DAS28-4(ESR) <=3.2 at week 36 [ Time Frame: week 36 ]
  • LDA as assessed by DAS28-4(CRP) <=3.2 at week 36 [ Time Frame: week 36 ]
  • LDA as assessed by CDAI<=10 at week 36 [ Time Frame: week 36 ]
  • LDA as assessed by SDAI<=11 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by ACR-EULAR Boolean remission criteria at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by DAS28-4 (ESR)<2.6 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by DAS28-4 (CRP)<2.6 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by CDAI≤2.8 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by SDAI≤3.3 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by ACR-EULAR Boolean remission criteria at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by DAS28-4 (ESR)<2.6 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by DAS28-4 (CRP)<2.6 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by CDAI≤2.8 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by SDAI≤3.3 at week 36 [ Time Frame: week 36 ]
  • ACR20 response at week 48 [ Time Frame: week 48 ]
  • ACR50 response at week 48 [ Time Frame: week 48 ]
  • ACR70 response at week 48 [ Time Frame: week 48 ]
  • ACR20 response at week 36 [ Time Frame: week 36 ]
  • ACR50 response at week 36 [ Time Frame: week 36 ]
  • ACR70 response at week 36 [ Time Frame: week 36 ]
  • Change in the HAQ-DI from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the SF-36 (8 domain scores and 2 component scores) from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the WPAI score from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the EuroQol EQ-5D score from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the FACIT-Fatigue scale score from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the HAQ-DI from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the SF-36 (8 domain scores and 2 component scores) from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the WPAI score from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the EuroQol EQ-5D score from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the FACIT-Fatigue scale score from week 24 to week 36 [ Time Frame: week 36 ]
  • HAQ-DI response (ie, decrease of at least 0.22) at week 48 [ Time Frame: week 48 ]
  • HAQ-DI response (ie, decrease of at least 0.22) at week 36 [ Time Frame: week 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
  • Change in the DAS28-4(ESR) from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the DAS28-4 (CRP) from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the CDAI from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in SDAI from week 24 to week 48 [ Time Frame: week 48 ]
  • change in the DAS28-4 (CRP) from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the CDAI from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the SDAI from week 24 to week 36 [ Time Frame: week 36 ]
  • LDA as assessed by DAS28-4(ESR) <3.2 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by DAS28-4(CRP) <3.2 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by CDAI<=10 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by SDAI<=11 at week 48 [ Time Frame: week 48 ]
  • LDA as assessed by DAS28-4(ESR) <3.2 at week 36 [ Time Frame: week 36 ]
  • LDA as assessed by DAS28-4(CRP) <3.2 at week 36 [ Time Frame: week 36 ]
  • LDA as assessed by CDAI<=10 at week 36 [ Time Frame: week 36 ]
  • LDA as assessed by SDAI<=11 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by ACR-EULAR Boolean remission criteria at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by DAS28-4 (ESR)<2.6 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by DAS28-4 (CRP)<2.6 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by CDAI≤2.8 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by SDAI≤3.3 at week 48 [ Time Frame: week 48 ]
  • Remission as assessed by ACR-EULAR Boolean remission criteria at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by DAS28-4 (ESR)<2.6 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by DAS28-4 (CRP)<2.6 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by CDAI≤2.8 at week 36 [ Time Frame: week 36 ]
  • Remission as assessed by SDAI≤3.3 at week 36 [ Time Frame: week 36 ]
  • ACR20 response at week 48 [ Time Frame: week 48 ]
  • ACR50 response at week 48 [ Time Frame: week 48 ]
  • ACR70 response at week 48 [ Time Frame: week 48 ]
  • ACR20 response at week 36 [ Time Frame: week 36 ]
  • ACR50 response at week 36 [ Time Frame: week 36 ]
  • ACR70 response at week 36 [ Time Frame: week 36 ]
  • Change in the HAQ-DI from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the SF-36 (8 domain scores and 2 component scores) from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the WPAI score from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the EuroQol EQ-5D score from week 24 t6o week 48 [ Time Frame: week 48 ]
  • Change in the FACIT-Fatigue scale score from week 24 to week 48 [ Time Frame: week 48 ]
  • Change in the HAQ-DI from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the SF-36 (8 domain scores and 2 component scores) from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the WPAI score from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the EuroQol EQ-5D score from week 24 to week 36 [ Time Frame: week 36 ]
  • Change in the FACIT-Fatigue scale score from week 24 to week 36 [ Time Frame: week 36 ]
  • HAQ-DI response (ie, decrease of at least 0.22) at week 48 [ Time Frame: week 48 ]
  • HAQ-DI response (ie, decrease of at least 0.22) at week 36 [ Time Frame: week 36 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis
Official Title  ICMJE A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION
Brief Summary This study is designed to evaluate the efficacy and safety of tofacitinib modified release formulation (11mg QD) versus tofacitinib modified release formulation plus continued methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are insufficiently responding to their stable dose of methotrexate treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CP-690,550

    During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.

    During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above.

    Other Name: tofacitinib
  • Drug: Methotrexate

    During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.

    During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above.

  • Drug: Placebo
    During the double-blind phase, subjects who are randomized to the comparison arm will receive 11mg QD tofacitinib and the placebo capsules matching for methotrexate.
Study Arms  ICMJE
  • Experimental: CP-690,550 and methotrexate
    Open-label tofacitinib tablet and blinded methotrexate capsule
    Interventions:
    • Drug: CP-690,550
    • Drug: Methotrexate
  • Placebo Comparator: CP-690,550 and placebo
    open-label tofacitinib tablet and blinded matching placebo for methotrexate capsule
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2018)
695
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2016)
580
Actual Study Completion Date  ICMJE December 17, 2018
Actual Primary Completion Date November 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

- Must be 18 years of age or older.

Have a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis at and/or prior to Screening Visit.

  • Have ≥4 tender/painful joints on motion and ≥4 swollen joints (28 joint counts) at both Screening Visit and Baseline Visit (Visit 1).
  • Have moderate to severe disease activity as defined by CDAI>10 and DAS28-4(ESR) ≥3.2 at Baseline Visit.
  • Have taken an oral MTX treatment regimen (15-25mg/week) continuously for at least 4 months prior to the screening visit and has taken a stable weekly dose of oral MTX with supplemental folic acid or folinic acid for at least 4 weeks prior to the baseline visit (conversion from parenteral MTX to oral MTX will require stabilization of the treatment regimen for at least 1 month).
  • Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis infection (active or latent).

Key Exclusion Criteria

  • Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
  • Subjects with infection or infection history; subjects with any current malignancy or a history of malignancy (except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ); subjects with history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic); and subjects with history of documented diverticulitis.
  • Subjects with a history of insufficient response to ≥2 biologics, regardless of the class.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   Czechia,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02831855
Other Study ID Numbers  ICMJE A3921192
2016-001825-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP