A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease

Study Overview
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Brief Summary
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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 of the dose levels to be tested will be more effective than placebo (inactive drug).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be at least 18 years of age at screening Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive Exclusion Criteria: Subjects currently receiving immunosuppressants, interferon, anti-TNFa Subjects with evidence of hematopoietic disorders Subjects with evidence of active or latent TB

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1mg BD<br> | Drug: CP-690,550<br>* administration via oral route twice daily<br>|
| Experimental: 5mg BD<br> | Drug: CP-690,550<br>* administration via oral route twice daily<br>|
| Experimental: 15mg BD<br> | Drug: CP-690,550<br>* administration via oral route twice daily<br>|
| Placebo Comparator: Placebo BID<br> | Drug: Placebo<br>* administration via oral route twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Response 70 at Week 4 | Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Response 70 at Week 1 and 2 | Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. | Week 1, 2 | 
| Number of Participants Achieving Clinical Remission at Week 4 | Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. | Week 4 | 
| Number of Participants With Clinical Response 100 at Week 4 | Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. | Week 4 | 
| Time to First Clinical Remission | Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. | Week 1 through Week 4 | 
| Time to First Response 70 | Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity. | Week 1 through Week 4 | 
| Time to First Response 100 | Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. | Week 1 through Week 4 |