An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

Conditions

• Colitis, Ulcerative

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — BIOLOGICAL
  Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
• Golimumab 100 mg — BIOLOGICAL
  Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -\> 50 mg arm group and at Week 2 for Golimumab 200 mg -\> 100 mg arm group.
• Golimumab 200 mg — BIOLOGICAL
  Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -\> 100 mg arm group and at Week 2 for Golimumab 400 mg -\> 200 mg arm group.
• Golimumab 400 mg — BIOLOGICAL
  Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -\> 200 mg arm group.
• Golimumab 50 mg — BIOLOGICAL
  Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -\> 50 mg arm group.

Study Details

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).

Key Dates

Start date

Aug 31, 2007

Status verified

Jan 2014

Primary completion

Oct 31, 2010

Completion

Oct 31, 2010

Study Design

Enrollment

1,065 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
• Experimental: Golimumab 100 mg -> 50 mg
  Golimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2.
• Experimental: Golimumab 200 mg -> 100 mg
  Golimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2.
• Experimental: Golimumab 400 mg -> 200 mg
  Golimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2.

Primary Outcome Measure

Number of Participants With Clinical Response at Week 6 [ Time Frame: Baseline, Week 6 ]

Locations (58)

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