Phase 3
Completed N=1,228
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT00488631 ↗
Enrolled (actual)
1,228
Serious AEs
13.8%
Results posted
Nov 2013
Primary outcomePrimary: Number of Participants in Clinical Response Through Week 54 — 48; 71; 75 Participants — p=0.010
Summary
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Clinical Response Through Week 54 |
48; 71; 75 | 0.010 sig |
| SECONDARY Number of Participants With Clinical Remission at Both Week 30 and Week 54 |
24; 35; 42 | 0.122 |
| SECONDARY Number of Participants With Mucosal Healing at Both Week 30 and Week 54 |
41; 63; 64 | 0.011 sig |
| SECONDARY Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study |
13; 19; 21 | 0.365 |
| SECONDARY Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study |
16; 22; 19 | 0.279 |
Eligibility Criteria
Inclusion Criteria
- Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Exclusion Criteria
- Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C
- Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)
Data sourced from ClinicalTrials.gov (NCT00488631). 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.