Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Active Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: SBI-087

Study type: Interventional

Funder types: Industry

Identifiers

NCT01008852

B2261003

3227K1-2000

Details and patient eligibility

About

This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
• Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
• Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
• Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

Exclusion criteria

• Any significant health problem other than rheumatoid arthritis
• Any clinically significant laboratory abnormalities
• Any prior use of B cell-depleting therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 5 patient groups, including a placebo group

Treatment Group 1

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Treatment Group 2

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Treatment Group 3

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Treatment Group 4

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Treatment Group 5

Placebo Comparator group

Treatment:

Drug: Placebo