Phase 3
Completed N=593
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Source: ClinicalTrials.gov NCT01458574 ↗Enrolled (actual)
593
Serious AEs
5.7%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants In Remission at Week 52 — 34.3; 40.6; 11.1 percentage of participants — p=<0.0001
◆ Published Evidence
Highly cited
116citations · ~39 / year
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance.
Summary
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
Linked Publications (5)
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Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance.
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Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure.
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Major Adverse Cardiovascular Events by Baseline Cardiovascular Risk in Patients with Ulcerative Colitis Treated with Tofacitinib: Data from the OCTAVE Clinical Programme.
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Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis.
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Presence of risk factors associated with colectomy among patients with ulcerative colitis: a <i>post hoc</i> analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants In Remission at Week 52 |
34.3; 40.6; 11.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 52 |
37.4; 45.7; 13.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline |
35.4; 47.3; 5.1 | <0.0001 sig |
| SECONDARY Percentage of Participants in Remission at Week 24 |
33.8; 35.5; 11.1 | <0.0001 sig |
| SECONDARY Percentage of Participants in Sustained Remission |
22.2; 25.4; 5.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 24 |
43.9; 46.2; 17.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Mucosal Healing |
27.8; 33.0; 6.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline |
52.4; 66.3; 21.8; 41.9; 55.1; 11.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline |
33.3; 49.4; 8.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Clinical Response at Week 24 and 52 |
63.6; 70.6; 33.3; 51.5; 61.9; 20.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Sustained Clinical Response |
49.0; 59.4; 19.2 | <0.0001 sig |
| SECONDARY Percentage of Participants in Clinical Remission at Week 24 and 52 |
34.3; 35.5; 11.1; 34.3; 41.1; 11.1 | <0.0001 sig |
| SECONDARY Percentage of Participants in Sustained Clinical Remission |
22.2; 25.9; 5.1 | <0.0001 sig |
| SECONDARY Percentage of Participants in Deep Remission at Week 24 and 52 |
14.1; 10.7; 4.0; 14.6; 15.2; 4.0 | 0.0006 sig |
| SECONDARY Percentage of Participants in Sustained Deep Remission |
6.1; 3.6; 0.5 | 0.0029 sig |
| SECONDARY Percentage of Participants in Symptomatic Remission at Week 24 and 52 |
23.7; 21.8; 6.6; 22.7; 26.9; 7.1 | <0.0001 sig |
| SECONDARY Percentage of Participants in Sustained Symptomatic Remission |
13.6; 15.7; 2.5 | <0.0001 sig |
| SECONDARY Percentage of Participants in Endoscopic Remission at Week 24 and 52 |
16.2; 12.2; 4.0; 14.6; 16.8; 4.0 | <0.0001 sig |
| SECONDARY Percentage of Participants in Sustained Endoscopic Remission |
6.1; 5.1; 0.5 | 0.0029 sig |
| SECONDARY Total Mayo Score at Baseline, Week 24 and 52 |
3.3; 3.4; 3.3; 4.1; 4.0; 6.7 | — |
| SECONDARY Change From Baseline in Total Mayo Score at Week 24 and 52 |
0.3; 0.0; 2.9; 0.4; -0.4; 2.9 | <0.0001 sig |
| SECONDARY Percentage of Participants in Remission, Among Participants With Remission at Baseline |
55.4; 63.6; 15.3; 46.2; 56.4; 10.2 | <0.0001 sig |
| SECONDARY Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline |
36.9; 47.3; 5.1 | <0.0001 sig |
| SECONDARY Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline |
53.8; 63.6; 15.3; 44.6; 56.4; 10.2 | <0.0001 sig |
| SECONDARY Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline |
23.8; 24.1; 10.9; 27.7; 27.6; 10.9 | 0.0074 sig |
| SECONDARY Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline |
12.9; 16.1; 5.0 | 0.0419 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
- Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.
Data sourced from ClinicalTrials.gov (NCT01458574) and the linked publication. 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.