The Safety And Efficacy Of Maintenance Therapy With CP-690,550

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01393899
• Date of registration: 12/07/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: The Safety And Efficacy Of Maintenance Therapy With CP-690,550
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
• Date of first enrolment: March 2012
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01393899
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Japan, Korea, Republic of, Netherlands, South Africa, Spain, Ukraine, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: CP-690,550

Drug: Placebo

Primary Outcome(s)

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 [Time Frame: Week 26]

Secondary Outcome(s)

Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study [Time Frame: Weeks 4, 8, 12, 20 and 26]

Change From Baseline in CDAI Score by Week [Time Frame: Weeks 4, 8, 12, 20 and 26]

Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26 [Time Frame: Weeks 4, 8, 12, 20 and 26]

Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose [Time Frame: Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit]

Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline [Time Frame: Week 26]

Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26 [Time Frame: Weeks 4, 8, 12, 20 and 26]

Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20 [Time Frame: Weeks 4, 8, 12 and 20]

CDAI Score by Week [Time Frame: Baseline and Weeks 4, 8, 12, 20 and 26]

Kaplan-Meier Estimate of the Rate of Time to Relapse [Time Frame: Weeks 4, 8 12, 20 and 26]

Change From Baseline in Fecal Calprotectin by Week [Time Frame: Weeks 8, 12 and 26]

C-Reactive Protein (CRP) by Week [Time Frame: Baseline and Weeks 4, 8, 12, 20 and 26]

Fecal Calprotectin by Week [Time Frame: Baseline and Weeks 8, 12 and 26]

Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase [Time Frame: Weeks 20 and 26]

Change From Baseline in CRP by Week [Time Frame: Weeks 4, 8, 12, 20 and 26]

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 [Time Frame: Weeks 20 and 26]

Secondary ID(s)

2011-001754-28

A3921084

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01393899