Submitted by: Karen Solis 2017-04-19 00:00:00 Last Updated by: Karen Solis 2019-03-19 16:49:20


Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis  

PHRR170428-001532

A3921192

2016-CT0391

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

Study A391192 is a phase 3b/4 randomized double blind placebo controlled study of methotrexate (MTX) withdrawal in subjects with RA treated with tofacitinib 11mg MR formulation.

 

The study objective is to compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX, as measured by the change in the Disease Activity Score utilizing 4 components including erythrocyte sedimentation rate (DAS28-4 (ESR)) from randomization (at Week 24) to the end of the double-blind MTX withdrawal phase (at Week 48).

 

Start Date Duration in Months Target Completion Date Actual Completion Date
2016-09-01 31 2019-04-01 2019-03-20

Completed

Institution Classification Region LTO #
Pfizer Inc. Private Business NCR N/A
Institution Region
Pfizer Inc. - USA United States of America
Name E-Mail Institution and Institution Address
ClinicalTrials.gov call Center clinicaltrials.govcallcenter@pfizer.com Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA
Name E-Mail Institution and Institution Address
ClinicalTrials.gov call Center clinicaltrials.govcallcenter@pfizer.com Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA
Name Expertise Affiliation
Caroline G. Arroyo, MD Principal Investigator Iloilo Doctor's Hospital
Harold Michael P. Gomez, MD Principal Investigator Angeles University Foundation Medical Center
Llewellyn T. Hao, MD Principal Investigator Davao Doctors Hospital
Maria Sheila Leynes, MD Principal Investigator Mary Mediatrix Medical Center
Merle Y. Barba, MD Principal Investigator Cebu Doctors' University Hospital
Michael L. Tee, MD Principal Investigator Medical Center Manila
Roger Dulos, MD Principal Investigator St. Paul's Hospital of Iloilo, Inc.
Rosario P. Baes, MD Principal Investigator FEU - Dr. Nicanor Reyes Medical Foundation
Project Location Institutional Ethics Review Board
Iloilo Doctor's Hospital N/A
Angeles University Foundation Medical Center Angeles University Foundation Medical Center Institutional Ethics Review Committee
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
Mary Mediatrix Medical Center Mary Mediatrix Medical Center Research Ethics Review Committee
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
Medical Center Manila Manila Medical Ethics Review Committee
St. Paul's Hospital of Iloilo, Inc. St. Paul’s Hospital Iloilo – Institutional Ethics Review Board
FEU - Dr. Nicanor Reyes Medical Foundation N/A

Moderate to severe rheumatoid arthritis

To compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX, as measured by the change in the Disease Activity Score utilizing 4 components including erythrocyte sedimentation rate (DAS28-4 (ESR)) from randomization (at Week 24) to the end of the double-blind MTX withdrawal phase (at Week 48)

To compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX in the double-blind MTX withdrawal phase (at Week 36), as measured by DAS28‑4 (ESR).
 
To compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX in the double-blind MTX withdrawal phase (at Weeks 48 and 36), as measured by Disease Activity Score 28‑4 (C‑reactive protein) (DAS28‑4 (CRP)), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Low Disease Activity (LDA), remission, ACR20, ACR 50, and ACR 70.
 
To compare effects of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX on health outcome measures in the double-blind MTX withdrawal phase (at Weeks 48 and 36), as measured by Health Assessment Disability Questionnaire-Disability Index (HAQ‑DI), Medical Outcomes Survey Short Form -36 (SF-36), Work Productivity and Activity Impairment (WPAI), European Quality of Life ‑ 5 dimensions questionnaire (EuroQol EQ‑5D), and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale.
 
To evaluate the safety and tolerability of tofacitinib MR 11mg monotherapy versus tofacitinib MR 11mg with continued MTX.

Pending

  • Philippines

Clinical Trial

A3921192

CTA-2017-03-10-12

2017-03-13

0000-00-00

32

Unspecified

Unspecified

01 Sep 2016

Inclusion Criteria:
a. Must be 18 years of age or older.
 
b. 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).
 
Exclusion Criteria:
a. 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.
 
b. 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.
 
c. Subjects with a history of insufficient response to ≥2 biologics, regardless of the class.

Interventional

Tofacitinib Citrate (CP 690,550) Modified Release (MR) Tablet

Intervention Description: 
 
a. Product Name: Tofacitinib Citrate
b. Product Code: CP 690,550
c. Pharmaceutical form: Modified Release (MR) Tablet
d. Specific pediatric formulation: No
e. Routes of administration: Oral Use
f. Concentration unit: milligram(s)
g. Concentration number: 11
h. IMP contains: Active substance of chemical origin

None

Randomized

Double Blind

Unspecified

Parallel

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.

Phase III

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