Phase 3
Completed N=1,065
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT00487539 ↗
Enrolled (actual)
1,065
Serious AEs
4.5%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With Clinical Response at Week 6 — 76; 129; 141 Participants — p=<0.0001
Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response at Week 6 |
76; 129; 141 | <0.0001 sig |
| SECONDARY Number of Participants With Clinical Remission at Week 6 |
16; 45; 46 | <0.0001 sig |
| SECONDARY Number of Participants With Mucosal Healing at Week 6 |
72; 107; 116 | 0.0014 sig |
| SECONDARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 |
129.6; 131.7; 127.2; 14.8; 27.0; 26.9 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
- Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
- Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate, oral corticosteroids, 6-mercaptopurine and azathioprine
- Participants with current dependency or with a history of corticosteroid dependency (i.e., an inability to successfully taper corticosteroids without a return of the symptoms of UC)
- Not have a diagnosis of active tuberculosis
- Participants with negative stool test for enteric (by way of the intestines) pathogens
Exclusion Criteria
- Participants with prior exposure to biologic anti-tumor necrosis factor (TNF) agents
- Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
- Participants having UC limited to the rectum only or to less than 20 centimeter of the colon
- Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
- Participants with a history of extensive colonic resection
Data sourced from ClinicalTrials.gov (NCT00487539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.