A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

Part of paid clinical trials in Palm Harbor, Florida.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01645280
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo + methotrexate (MTX) (Group 1) — DRUG
    Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
  • Ustekinumab + MTX (Group 2) — DRUG
    Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
  • Ustekinumab + MTX (Group 3) — DRUG
    Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose)
  • CNTO 1959 + MTX (Group 4) — DRUG
    CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
  • CNTO 1959 + MTX (Group 5) — DRUG
    CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)

Study Details

The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.

Key Dates

Start date
Aug 31, 2012
Status verified
May 2016
Primary completion
Dec 31, 2013
Completion
May 31, 2014

Study Design

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

Arms

  • Placebo Comparator: Group 1
  • Experimental: Group 2
  • Experimental: Group 3
  • Experimental: Group 4
  • Experimental: Group 5

Primary Outcome Measure

Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28 [ Time Frame: Week 28 ]

Locations (3)

FacilityCityStateZIPSite coordinators
-Palm HarborFlorida--
-Rock IslandIllinois--
-St LouisMissouri--

Find similar trials in Palm Harbor, FL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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