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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02015520
• Date of registration: 06/12/2013
• Prospective Registration: No
• Primary sponsor: CSL Behring
• Public title: Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
• Scientific title: A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors
• Date of first enrolment: June 2012
• Target sample size: 143
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02015520
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Canada, France, Hungary, Italy, Japan, Mexico, South Africa, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo (Matching with Clazakizumab)

Drug: Clazakizumab

Primary Outcome(s)

Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP) change from baseline at Week 12 [Time Frame: Baseline (Day 1) and Week 12]

Secondary Outcome(s)

DAS28- Erythrocyte sedimentation rate (ESR) <2.6 [Time Frame: At week 12]

DAS28-CRP<2.6 [Time Frame: At week 12]

American College of Rheumatology (ACR) 20/50/70 Responses [Time Frame: At week 12]

Clinical Disease Activity Index (CDAI) [Time Frame: At week 12]

Health assessment questionnaire disability index (HAQ-DI) change from baseline at Week 12 [Time Frame: Baseline (Day 1) and Week 12]

Boolean Remission [Time Frame: At week 12]

Simplified Disease Activity Index (SDAI) [Time Frame: At week 12]

Safety based on adverse events (AEs), vital signs, physical examinations, safety lab values and immunogenicity during the double-blind period [Time Frame: Up to week 12]

Secondary ID(s)

2013-003780-65

IM133-066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors