Phase 2
Completed N=180
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
Source: ClinicalTrials.gov NCT01393899 ↗Enrolled (actual)
180
Serious AEs
11.7%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26 — 38.10; 39.53; 55.81 Percentage of participants
Summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26 |
38.10; 39.53; 55.81 | — |
| SECONDARY Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20 |
73.81; 74.42; 79.07; 66.67; 67.44; 58.14 | — |
| SECONDARY Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26 |
73.81; 72.09; 76.74; 66.67; 62.79; 58.14 | — |
| SECONDARY Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26 |
52.38; 55.81; 58.14; 47.62; 48.84; 39.53 | — |
| SECONDARY Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study |
72.00; 78.57; 80.77; 64.00; 64.29; 50.00 | — |
| SECONDARY Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase |
21.43; 23.26; 39.53 | — |
| SECONDARY Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase |
33.33; 25.58; 51.16 | — |
| SECONDARY CDAI Score by Week |
135.05; 127.23; 133.98; 168.24; 133.48; 143.45 | — |
| SECONDARY Change From Baseline in CDAI Score by Week |
33.17; 5.85; 11.02; 39.85; 20.32; 101.96 | =0.0637 |
| SECONDARY Kaplan-Meier Estimate of the Rate of Time to Relapse |
14.58; 7.14; 11.63; 21.90; 14.47; 23.51 | — |
| SECONDARY Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline |
16.67; 27.27; 33.33 | — |
| SECONDARY C-Reactive Protein (CRP) by Week |
8.08; 7.08; 8.59; 16.08; 8.04; 7.62 | — |
| SECONDARY Change From Baseline in CRP by Week |
10.66; 0.84; -0.97; 10.33; 0.96; 1.29 | <0.0001 sig |
| SECONDARY Fecal Calprotectin by Week |
380.43; 351.39; 399.33; 440.81; 295.39; 283.76 | — |
| SECONDARY Change From Baseline in Fecal Calprotectin by Week |
69.22; -59.73; -123.95; 103.55; -1.81; -107.04 | =0.0566 |
| SECONDARY Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose |
6.059; 6.832; 31.56; 58.53; 47.05; 85.23 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
- Women of childbearing potential must test negative for pregnancy prior to study enrolment.
Exclusion Criteria
- Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
- Subjects likely to require any type of surgery during the study period.
- Fecal culture/toxin assay indicating presence of pathogenic infection.
Data sourced from ClinicalTrials.gov (NCT01393899). 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.