Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate Placebo; Drug: BMS-945429 Placebo; Drug: Methotrexate; Drug: Adalimumab Placebo; Drug: Adalimumab; Biological: BMS-945429

Study type: Interventional

Funder types: Industry

Identifiers

NCT01373151

IM133-001

2010-023956-99 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Enrollment: 418 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inadequate response to Methotrexate
• Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
• American College of Rheumatology (ACR) global function status class 1-3
• Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
• High sensitivity C-reactive protein (hsCRP) ≥ 0.8 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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418 participants in 7 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Drug: Methotrexate

Drug: Adalimumab Placebo

Drug: Methotrexate

Biological: BMS-945429

Drug: Methotrexate

Biological: BMS-945429

Drug: BMS-945429 Placebo

Arm 2

Experimental group

Description:

BMS-945429 + Methotrexate + Adalimumab Placebo

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Drug: Methotrexate

Drug: Adalimumab Placebo

Drug: Methotrexate

Biological: BMS-945429

Drug: Methotrexate

Biological: BMS-945429

Arm 3

Experimental group

Description:

BMS-945429 + Methotrexate + Adalimumab Placebo

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Drug: Methotrexate

Drug: Adalimumab Placebo

Drug: Methotrexate

Biological: BMS-945429

Drug: Methotrexate

Biological: BMS-945429

Arm 4

Experimental group

Description:

BMS-945429 + Methotrexate + Adalimumab Placebo

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Drug: Methotrexate

Drug: Adalimumab Placebo

Drug: Methotrexate

Biological: BMS-945429

Drug: Methotrexate

Biological: BMS-945429

Arm 5

Experimental group

Description:

BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Drug: Methotrexate

Drug: Adalimumab Placebo

Drug: Methotrexate

Biological: BMS-945429

Drug: Methotrexate

Drug: Methotrexate Placebo

Biological: BMS-945429

Arm 6

Experimental group

Description:

BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo

Treatment:

Biological: BMS-945429

Biological: BMS-945429

Drug: Methotrexate

Drug: Adalimumab Placebo

Drug: Methotrexate

Biological: BMS-945429

Drug: Methotrexate

Drug: Methotrexate Placebo

Biological: BMS-945429

Arm 7

Active Comparator group

Description:

Adalimumab + Methotrexate

Treatment:

Drug: Methotrexate

Drug: Adalimumab

Drug: Methotrexate

Drug: Methotrexate