Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tofacitinib plus placebo methotrexate; Drug: Tasocitinib plus Methotrexate; Drug: Placebo tofacitinib plus Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01164579

2010-020890-18 (EudraCT Number)

A3921068

Details and patient eligibility

About

Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive.

Exclusion criteria

• Pregnant or lactating patients;
• Patients with renal or hepatic impairment or other severe or progressing disease;
• Patients with contraindication to magnetic resonance imaging with gadolinium contrast.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 3 patient groups

Tofacitinib (CP 690,550) 10 mg BID plus MTX

Experimental group

Treatment:

Drug: Tasocitinib plus Methotrexate

Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX

Experimental group

Treatment:

Drug: Tofacitinib plus placebo methotrexate

Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk

Active Comparator group

Treatment:

Drug: Placebo tofacitinib plus Methotrexate