A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: CP-690,550; Drug: CP 690,550; Biological: Biologic TNFi; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853385

A3921064

Details and patient eligibility

About

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Enrollment: 717 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
• The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
• The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion criteria

• Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L
• History of any other autoimmune rheumatic disease other than Sjogren's syndrome
• No malignancy or history of malignancy.
• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
• Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
• Patients who have previously received adalimumab therapy for any reason.
• Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
• Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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717 participants in 5 patient groups, including a placebo group

5mg

Experimental group

Treatment:

Drug: CP 690,550

10 mg

Experimental group

Treatment:

Drug: CP-690,550

Placebo Sequence 1

Placebo Comparator group

Treatment:

Other: Placebo

Other: Placebo

Placebo Sequence 2

Placebo Comparator group

Treatment:

Other: Placebo

Other: Placebo

adalimumab

Active Comparator group

Treatment:

Biological: Biologic TNFi