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

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ClinicalTrials.gov Identifier: NCT02015520
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Vitaeris INC

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Clazakizumab Drug: Placebo (Matching with Clazakizumab) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Clazakizumab (Dose # A) (Double-Blind)
Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate
Drug: Clazakizumab
Other Name: BMS-945429

Experimental: Arm 2: Clazakizumab (Dose # B) (Double-Blind)
Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate
Drug: Clazakizumab
Other Name: BMS-945429

Experimental: Arm 3: Clazakizumab (Dose # C) (Double-Blind)
Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate
Drug: Clazakizumab
Other Name: BMS-945429

Experimental: Arm 4: Placebo matching with Clazakizumab (Double-Blind)
Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate
Drug: Placebo (Matching with Clazakizumab)
Experimental: Arm 5: Clazakizumab (Dose# A) (Open Label)
Any subject who completes Double-Blind will receive Clazakizumab Dose # A injection by subcutaneous + background Methotrexate for 96 weeks
Drug: Clazakizumab
Other Name: BMS-945429




Primary Outcome Measures :
  1. 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 Measures :
  1. American College of Rheumatology (ACR) 20/50/70 Responses [ Time Frame: At week 12 ]
  2. Clinical Disease Activity Index (CDAI) [ Time Frame: At week 12 ]
  3. Simplified Disease Activity Index (SDAI) [ Time Frame: At week 12 ]
  4. Boolean Remission [ Time Frame: At week 12 ]
  5. Health assessment questionnaire disability index (HAQ-DI) change from baseline at Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
  6. DAS28- Erythrocyte sedimentation rate (ESR) <2.6 [ Time Frame: At week 12 ]
  7. DAS28-CRP<2.6 [ Time Frame: At week 12 ]
  8. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015520


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Sponsors and Collaborators
Vitaeris INC
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Vitaeris INC
ClinicalTrials.gov Identifier: NCT02015520     History of Changes
Other Study ID Numbers: IM133-066
2013-003780-65 ( EudraCT Number )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases