Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Other: Placebo; Drug: ILV-094

Study type: Interventional

Funder types: Industry

Identifiers

NCT00883896

3199K1-2001

B1981001

2008-006936-37 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.

Enrollment: 195 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 at the time of screening and baseline consisting of >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
• Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.

Exclusion criteria

• Subjects with other rheumatic diseases
• Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
• 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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195 participants in 5 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Part 1: Placebo

Treatment:

Other: Placebo

Other: Placebo

Arm 2

Experimental group

Description:

Part 1: 100 mg ILV-094 SC Q4W

Treatment:

Drug: ILV-094

Drug: ILV-094

Drug: ILV-094

Arm 3

Experimental group

Description:

Part 1: 100 mg ILV-094 SC Q2W

Treatment:

Drug: ILV-094

Drug: ILV-094

Drug: ILV-094

Arm 4

Placebo Comparator group

Treatment:

Other: Placebo

Other: Placebo

Arm 5

Experimental group

Description:

Part 2: 200 mg ILV-094 SC Q2W

Treatment:

Drug: ILV-094

Drug: ILV-094

Drug: ILV-094