Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Arthritis, Psoriatic

Treatments: Biological: BMS-945429; Biological: Placebo matching BMS-945429

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490450

2011-004016-29 (EudraCT Number)

IM133-004

Details and patient eligibility

About

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
• Inadequate response to NSAID and/or non-biologic DMARD
• Minimum of 3 swollen and 3 tender joints
• Active psoriatic skin lesions over minimum 3% body surface area
• high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

Exclusion criteria

• Previously received or currently receiving concomitant biologic therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 4 patient groups, including a placebo group

PBO: Placebo matching BMS-945429

Placebo Comparator group

Treatment:

Biological: Placebo matching BMS-945429

BMS-945429 (25mg)

Experimental group

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

BMS-945429 (100mg)

Experimental group

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429

BMS-945429 (200mg)

Experimental group

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Biological: BMS-945429