Recruitment

Recruitment Status
Completed
Estimated Enrollment
140

Inclusion Criterias

ACR global functional status class of 1 to 3
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
Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
...
ACR global functional status class of 1 to 3
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
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 Criterias

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

ACR global functional status class of 1 to 3
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
Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
...
ACR global functional status class of 1 to 3
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
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 Criterias

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

Locations

Shinjuku-Ku, Tokyo, 1608582
Nagano-shi, Nagano, 3808582
Leon, Guanajuato, 37000
Napoli, 80131
Lincoln, Nebraska, 68516
...
Shinjuku-Ku, Tokyo, 1608582
Nagano-shi, Nagano, 3808582
Leon, Guanajuato, 37000
Napoli, 80131
Lincoln, Nebraska, 68516
Merida, Yucatan, 97070
Albuquerque, New Mexico, 87102
Hamilton, Ontario, L8N 2B6
Buenos Aires, 1121
Sarasota, Florida, 34239
Kitakyushu-shi, Fukuoka, 8078555
Eagan, Minnesota, 55121
Long Beach, California, 90806
Cape Town, Western CAPE, 7500
Tulsa, Oklahoma, 74135
Bordeaux Cedex, 33076
Buenos Aires, 1426
Oklahoma City, Oklahoma, 73103
Charleston, South Carolina, 29406
Oklahoma City, Oklahoma, 73103
Toshima-ku, Tokyo, 1708476
Pisa, 56126
Mississauga, Ontario, L5M 2V8
Cordoba, 5000
Greenville, North Carolina, 27834
Albuquerque, New Mexico, 87102
Knoxville, Tennessee, 37909
Chiba-shi, Chiba, 2608712
Firenze, 50139
Guadalajara
San Luis Potosi, 78200
Kato-shi, Hyogo, 6731462
Palm Desert, California, 92260
Worcester, Massachusetts, 01605
Nashville, Tennessee, 37203
Hot Springs, Arkansas, 71913
Sasebo-shi, Nagasaki, 8571195
Middleburg Heights, Ohio, 44130
Nishimura, Wakayama, 6492211
Huntsville, Alabama, 35801
Debrecen, 4012
Saskatoon, Saskatchewan, S7K 3H3
Seattle, Washington, 98122
Tijuana, Baja California, 22010
Paris Cedex 14, 75679
Quilmes, Buenos Aires, 1878
Charlotte, North Carolina, 28204
Budapest, 1023
Cincinnati, Ohio, 45219
Merida, Yucatan, 97000
Poitiers, 86021
Veszprem, 8200
Stellenbosch, Western Cape, 7600
Tucuman, 4000
Catanzaro, 88100

Tracking Information

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