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NCT00615199 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00615199
Other study ID # A3921043
Secondary ID
Status Completed
Phase Phase 2
First received January 14, 2008
Last updated January 18, 2013
Start date January 2008
Est. completion date October 2009

Study information
Verified date January 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 of the dose levels to be tested will be more effective than placebo (inactive drug).

Recruitment information / eligibility
Status Completed
Enrollment 139
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CP-690,550
administration via oral route twice daily
• CP-690,550
administration via oral route twice daily
• CP-690,550
administration via oral route twice daily
• Placebo
administration via oral route twice daily

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Leuven
Czech Republic Pfizer Investigational Site Hradec Kralove
Czech Republic Pfizer Investigational Site Usti nad Labem
France Pfizer Investigational Site Lille Cedex
France Pfizer Investigational Site Pessac Cedex
France Pfizer Investigational Site Vandoeuvre-les-nancy
Hungary Pfizer Investigational Site Bekescsaba
Hungary Pfizer Investigational Site Debrecen
Hungary Pfizer Investigational Site Gyor
Hungary Pfizer Investigational Site Gyula
Hungary Pfizer Investigational Site Kaposvar
Hungary Pfizer Investigational Site Szekszard
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Roma
Netherlands Pfizer Investigational Site Amsterdam
Poland Pfizer Investigational Site Lublin
Poland Pfizer Investigational Site Olsztyn
Poland Pfizer Investigational Site Wroclaw
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Nitra
South Africa Pfizer Investigational Site Cape Town Western Cape
South Africa Pfizer Investigational Site Durban
South Africa Pfizer Investigational Site Durban Kwa-Zulu Natal
South Africa Pfizer Investigational Site Durbanvilee Cape Town
South Africa Pfizer Investigational Site Johannesburg Gauteng
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site L'hospitalet de Llobregat Barcelona
Spain Pfizer Investigational Site Majadahonda Madrid
United Kingdom Pfizer Investigational Site Bristol
United Kingdom Pfizer Investigational Site Salford
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Boulder Colorado
United States Pfizer Investigational Site Bristol Tennessee
United States Pfizer Investigational Site Charleston West Virginia
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chevy Chase Maryland
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Duncansville Pennsylvania
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Great Neck New York
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Kingsport Tennessee
United States Pfizer Investigational Site Lakewood Colorado
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Mexico Missouri
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site Salisbury North Carolina
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site Towson Maryland
United States Pfizer Investigational Site Troy Michigan
United States Pfizer Investigational Site Upper St. Clair, Pennsylvania
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site Wheat Ridge Colorado
United States Pfizer Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  France,  Hungary,  Italy,  Netherlands,  Poland,  Slovakia,  South Africa,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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