Phase 2
Completed N=150
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Source: ClinicalTrials.gov NCT01470599 ↗Enrolled (actual)
150
Serious AEs
12.7%
Results posted
Oct 2017
Primary outcomePrimary: Adjudicated Potential Cardiovascular Events — 0 Number of events meeting criteria
Summary
The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjudicated Potential Cardiovascular Events |
— | — |
| PRIMARY Adjudicated Malignancy Events |
0; 1 | — |
| PRIMARY Adjudicated Hepatic Injury Events |
— | — |
| PRIMARY Adjudicated Opportunistic Infection Events |
1; 1 | — |
| PRIMARY Adjudicated Gastrointestinal (GI) Perforation Events |
2 | — |
| PRIMARY Adjudicated Interstitial Lung Disease (ILD) Events |
— | — |
| SECONDARY Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48 |
87.88; 55.56; 75.00; 34.29 | — |
| SECONDARY Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study |
100.00; 100.00; 75.47; 50.00; 84.62; 75.00 | — |
| SECONDARY Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study |
98.39; 17.39; 75.93; 35.00; 84.91; 36.84 | — |
| SECONDARY Time to Relapse Among Participants in Clinical Remission at Baseline |
6.78; NA; 11.86; 25.00; 15.46; 25.00 | — |
| SECONDARY Observed CDAI Score by Week |
77.13; 291.19; 105.39; 176.96; 86.58; 178.94 | — |
| SECONDARY Change From Baseline Observed CDAI Score by Week |
26.96; -114.31; 11.72; -112.02; 6.33; -122.69 | — |
| SECONDARY Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline |
50.00; 9.09 | — |
| SECONDARY Corticosteroid Use Over Time |
1.61; 20.45; 4.84; 21.59; 4.84; 13.64 | — |
| SECONDARY Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit |
0; 0; 25.81; 0; 6.45; 0 | — |
| SECONDARY Observed Change From Baseline in Fecal Calprotectin by Week |
-105.51; -102.82; -144.65; -35.28; -120.49; -130.68 | — |
| SECONDARY Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week |
-0.44; -4.81; -2.46; -7.96; -2.76; -9.26 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit |
187.23; 127.32; 179.26; 144.42; 58.56; 40.71 | — |
| SECONDARY Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit |
-7.98; 18.84; -2.72; 6.37; -3.07; 5.36 | — |
| SECONDARY Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit |
70.18; 31.33 | — |
| SECONDARY Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category |
0; 0; 0; 8.7; 0; 17.4 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit |
50.15; 37.80; 48.43; 41.87; 50.25; 37.17 | — |
| SECONDARY Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit |
-1.47; 4.47; -1.88; 3.07; -1.80; 3.49 | — |
| SECONDARY EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit |
0.85; 0.57; 0.84; 0.66 | — |
| SECONDARY Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit |
-0.02; 0.10 | — |
| SECONDARY EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit |
77.98; 48.60; 73.40; 57.60 | — |
| SECONDARY Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit |
-3.79; 10.16 | — |
| SECONDARY Percentage of Participants Hospitalized Due to Crohn's Disease |
11.3; 15.9 | — |
| SECONDARY Length of Hospitalizations Due to Crohn's Disease |
1.6; 2.3; 6.5; 10.2; 0; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
- Women of childbearing potential must test negative for pregnancy prior to study enrolment.
- Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.
Exclusion Criteria
- Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
- Subjects who were discontinued from the A3921084 study due to an adverse event.
- Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
Data sourced from ClinicalTrials.gov (NCT01470599). 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.