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

Last updated on March 26, 2019

FOR MORE INFORMATION
Study Location
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801-4418 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 takes weekly dose of oral MTX
with supplemental folic acid or folinic acid prior to first dose.

- Screen negative for active tuberculosis or inadequately treated
tuberculosis infection (active or latent).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 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 or more biologics, regardless of the
class.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Capsules
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
Duration
The time commitment for participation in the study.
Follow up: Estimated 28 days
Screening: Up to 30 days
Treatment: Up to 48 weeks
Site Visits
Follow up: visits
Screening: Estimated 1 visits
Treatment: Up to 6 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Blood test
Electrocardiogram (ECG)
Keeping a diary
Physical examination
Questionnaire
Urine test
Vital signs and measurements
X-rays
NCT02831855
Pfizer
Completed
Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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