An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Golimumab 100 mg — DRUG
  Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.
• Golimumab 50 mg — DRUG
  Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.
• Methotrexate — DRUG
  Participants will receive methotrexate capsules weekly.
• Placebo injection — DRUG
  Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.
• Placebo capsules — DRUG
  Participants will receive placebo capsules weekly

Study Details

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.

Key Dates

Start date

Dec 31, 2005

Status verified

Apr 2014

Primary completion

Sep 30, 2007

Completion

May 31, 2012

Study Design

Enrollment

444 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Group 1: Placebo + Methotrexate
  Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
• Experimental: Group 2: Golimumab 100 mg + Placebo
  Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7-10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
• Experimental: Group 3: Golimumab 50 mg + Methotrexate
  Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.
• Experimental: Group 4: Golimumab 100 mg + Methotrexate
  Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.

Primary Outcome Measure

Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 [ Time Frame: Week 14 ]

Locations (13)

Find similar trials in Mobile, AL

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