Recruitment

Recruitment Status
Completed
Estimated Enrollment
140

Inclusion Criteria

ACR global functional status class of 1 to 3
Elevated High-sensitivity (hs) CRP and/or ESR
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
Elevated High-sensitivity (hs) CRP and/or ESR
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
Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
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

Exclusion Criteria

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

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

ACR global functional status class of 1 to 3
Elevated High-sensitivity (hs) CRP and/or ESR
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
Elevated High-sensitivity (hs) CRP and/or ESR
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
Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02015520
Collaborators
Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb