Phase 2
Completed N=279
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Source: ClinicalTrials.gov NCT01393626 ↗Enrolled (actual)
279
Serious AEs
5.7%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8 — 36.67; 43.53; 43.02 Percentage of Participants — p=0.3249
Summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8 |
36.67; 43.53; 43.02 | 0.3249 |
| SECONDARY Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 |
10.00; 9.41; 9.30; 21.11; 24.71; 22.09 | — |
| SECONDARY Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8 |
37.78; 47.06; 44.19; 50.00; 57.65; 56.98 | — |
| SECONDARY Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8 |
23.33; 34.12; 32.56; 37.78; 48.24; 45.35 | — |
| SECONDARY Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 |
24.44; 34.12; 32.56; 38.89; 49.41; 46.51 | — |
| SECONDARY CDAI Scores at Weeks 2, 4, and 8 |
258.04; 237.60; 241.21; 270.31; 228.65; 213.38 | — |
| SECONDARY C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 |
17.28; 8.26; 8.56; 7.89; 18.94; 8.17 | — |
| SECONDARY Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 |
492.95; 384.81; 403.35; 455.10; 493.26; 467.09 | — |
| SECONDARY Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit |
0.006687; 1.193; NA; 27.44; 62.28; 65.83 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit |
118.50; 117.89; 113.67; 124.19; 144.99; 159.14 | — |
| SECONDARY Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA) |
26.58; 41.20; 40.05; 8.36; 13.76; 13.88 | — |
| SECONDARY Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit |
26.1; 45.2; 43.2; 43.8 | — |
| SECONDARY Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit |
61.4; 75.0; 76.5; 75.0 | — |
| SECONDARY Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category |
17.0; 6.0; 7.4; 6.3; 10.2; 9.6 | — |
| SECONDARY Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit |
37.12; 38.49; 35.28; 37.09; 40.84; 45.23 | — |
| SECONDARY Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA |
3.72; 7.28; 8.07; 6.47; 7.88; 7.13 | — |
| SECONDARY EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit |
0.56; 0.58; 0.49; 0.61; 0.64; 0.71 | — |
| SECONDARY Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA |
0.08; 0.14; 0.16 | — |
| SECONDARY EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit |
46.83; 49.51; 42.74; 52.06; 58.32; 67.07 | — |
| SECONDARY Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA |
11.97; 19.56; 20.62 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).
- Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
- Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.
Exclusion Criteria
- Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
- Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).
- Subjects receiving the following treatment for Crohn's disease:
- Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
- Anti-TNFα therapy within 8 weeks prior to baseline.
- Interferon therapy within 8 weeks prior to baseline.
- Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
- Intravenous corticosteroids within 2 weeks prior to baseline.
Data sourced from ClinicalTrials.gov (NCT01393626). 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.