Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

Part of paid clinical trials in Peoria, Arizona.

Sponsor
CSL Behring
Study ID
NCT01373151
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-945429 Placebo — DRUG
    Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
  • BMS-945429 — BIOLOGICAL
    Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
  • BMS-945429 — BIOLOGICAL
    Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
  • BMS-945429 — BIOLOGICAL
    Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
  • BMS-945429 — BIOLOGICAL
    Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
  • Methotrexate — DRUG
    Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
  • Methotrexate — DRUG
    Tablets, Oral, 15 mg, Weekly, 48 weeks
  • Methotrexate Placebo — DRUG
    Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
  • Methotrexate — DRUG
    Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
  • Adalimumab Placebo — DRUG
    Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
  • Adalimumab — DRUG
    Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks

Study Details

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Key Dates

Start date
Jun 30, 2011
Status verified
Nov 2021
Primary completion
Sep 30, 2012
Completion
Jun 30, 2015

Study Design

Enrollment
418 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1
    BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
  • Experimental: Arm 2
    BMS-945429 + Methotrexate + Adalimumab Placebo
  • Experimental: Arm 3
    BMS-945429 + Methotrexate + Adalimumab Placebo
  • Experimental: Arm 4
    BMS-945429 + Methotrexate + Adalimumab Placebo
  • Experimental: Arm 5
    BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
  • Experimental: Arm 6
    BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
  • Active Comparator: Arm 7
    Adalimumab + Methotrexate

Primary Outcome Measure

Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate [ Time Frame: At 12 Weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Sun Valley Arthritis Center, Ltd.PeoriaArizona85381-
San Diego Arthritis Medical ClinicSan DiegoCalifornia92108-
New England Research Associates, LlcTrumbullConnecticut06611-
Quincy Medical GroupQuincyIllinois62301-
Rockford Orthopedic Associates, Llc.RockfordIllinois61107-
Clinical Pharmacology Study GroupWorcesterMassachusetts01605-
Arthritis Associates Of MississippiJacksonMississippi39202-
Physician Research Collaboration, LlcLincolnNebraska68516-
Box Arthritis And Rheumatology Of The Carolinas, PllcCharlotteNorth Carolina28210-
Health Research Of OklahomaOklahoma CityOklahoma73103-
East Penn Rheumatology Associates, P.C.BethlehemPennsylvania18015-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Seattle Rheumatology AssociatesSeattleWashington98104-

Find similar trials in Peoria, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Sun Valley Arthritis Center, Ltd.· Peoria, AZSan Diego Arthritis Medical Clinic· San Diego, CANew England Research Associates, Llc· Trumbull, CTQuincy Medical Group· Quincy, ILRockford Orthopedic Associates, Llc.· Rockford, ILClinical Pharmacology Study Group· Worcester, MA

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