Phase 3
N=944
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT01470612 ↗Enrolled (actual)
944
Serious AEs
19.7%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 154; 626; 39; 147 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CP-690,550 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
154; 626; 39; 147 | — |
| PRIMARY Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs) |
8; 31 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities |
162; 670 | — |
| PRIMARY Number of Participants With Vital Sign Abnormalities |
20; 113; 19; 44; 3; 13 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline |
84; 391 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events |
0.31; 0.11; 0.96; 0.68; 1.09; 1.00 | — |
| SECONDARY Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases |
131; 188; 129; 279; 103; 264 | — |
| SECONDARY Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) |
131; 188; 129; 279; 103; 264 | — |
| SECONDARY Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases |
132; 191; 129; 282; 104; 266 | — |
| SECONDARY Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) |
132; 191; 129; 282; 104; 266 | — |
| SECONDARY Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases |
158; 275; 152; 375; 155; 395 | — |
| SECONDARY Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) |
158; 275; 152; 375; 155; 395 | — |
| SECONDARY Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases |
152; 279; 140; 340; 119; 307 | — |
| SECONDARY Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) |
152; 279; 140; 340; 119; 307 | — |
| SECONDARY Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF) |
154; 419; 151; 395; 140; 365 | — |
Summary
This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
Eligibility Criteria
Inclusion Criteria
- Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
- Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.
Exclusion Criteria
- Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
- Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.
Data sourced from ClinicalTrials.gov (NCT01470612). 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.