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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:September 1, 2016
End Date:December 17, 2018

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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

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.


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.
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New Port Richey, Florida 34652
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Aventura, Florida 33180
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Baton Rouge, Louisiana 70809
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Battle Creek, Michigan 49015
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Bethlehem, Pennsylvania 18015
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Boca Raton, Florida 33486
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Broadmeadow, New South Wales
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Chesapeake, Virginia 23320
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Cincinnati, Ohio 45220
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Cypress, Texas 77429
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Dayton, Ohio 45417
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Debary, FL
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Duncansville, Pennsylvania 16635
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Fair Oaks, California 95628
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Fall River, Massachusetts 02720
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Freehold, New Jersey 07728
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Gilbert, AZ
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Granger, IN
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Greenville, North Carolina 27834
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Greenville, South Carolina 29601
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Hot Springs, Arkansas 71913
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Huntington Beach, California 92646
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46227
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Jacksonville, Florida 32207
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Marlton, New Jersey 08053
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Minot, North Dakota 58701
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Naples, Florida 34102
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13255 Tamiami Trail East
Naples, Florida 34102
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Oklahoma City, Oklahoma 73103
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Oklahoma City, Oklahoma 73104
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Orangeburg, South Carolina 29118
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6818 West Thunderbird Road
Peoria, Arizona 85381
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Port Richey, Florida 34668
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Port Richey, Florida 34668
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Quincy, Illinois 62301
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Rochester, New York 14618
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Salisbury, North Carolina 28144
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Wall, New Jersey 07719
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Worcester, Massachusetts 01610
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