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

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NCT02831855

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801-4418 United States
See other locations
Contact
1-800-718-1021
[email protected]
Downloads
Related Links
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.
Treatment: Up to 48 weeks
Follow up: Estimated 28 days
Screening: Up to 30 days
Site Visits
Treatment: Up to 6 visits
Follow up: visits
Screening: Estimated 1 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
Recruiting
Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

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Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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.
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
580
November 3, 2018
November 3, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Belgium,   Bulgaria,   Czechia,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
 
 
NCT02831855
A3921192
2016-001825-15 ( EudraCT Number )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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