Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo (Matching with Clazakizumab); Drug: Clazakizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02015520

IM133-066

2013-003780-65 (EudraCT Number)

Details and patient eligibility

About

The primary purpose of this study is to identify an appropriate dose of study medication.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American Rheumatism association (ARA) [1987] or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) [2010]) at least 16 weeks prior to screening
• ACR global functional status class of 1 to 3
• Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
• All subjects must have been receiving treatment with a minimum dose of 15 mg per week of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is permitted, if it is at a dose approved for the treatment of RA and the dose has been stable for at least 28 days prior to screening
• Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
• Elevated High-sensitivity (hs) CRP and/or ESR

Exclusion Criteria:

• Active serious infection
• History of or active tuberculosis (TB)
• Elevated liver function tests (LFTs)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 4 patient groups

Arm 1: Clazakizumab (Dose # A) (Double-Blind)

Experimental group

Description:

Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate

Treatment:

Drug: Clazakizumab

Arm 2: Clazakizumab (Dose # B) (Double-Blind)

Experimental group

Description:

Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate

Treatment:

Drug: Clazakizumab

Arm 3: Clazakizumab (Dose # C) (Double-Blind)

Experimental group

Description:

Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate

Treatment:

Drug: Clazakizumab

Arm 4: Placebo matching with Clazakizumab (Double-Blind)

Experimental group

Description:

Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate

Treatment:

Drug: Placebo (Matching with Clazakizumab)