A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tofacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02281552

TOFACITINIB QD P3 (Other Identifier)

A3921215

Details and patient eligibility

About

This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.

Enrollment: 209 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of rheumatoid arthritis
• currently taking a stable dose of methotrexate
• no evidence of active or latent or inadequately treated tuberculosis

Exclusion criteria

• evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease
• clinically significant infections within the past 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

209 participants in 2 patient groups

tofacitinib modified release tablet

Experimental group

Treatment:

Drug: Tofacitinib

Drug: Tofacitinib

tofacitinib immediate release tablet

Active Comparator group

Treatment:

Drug: Tofacitinib

Drug: Tofacitinib