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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-690,550
CP-690,550
CP-690,550
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1mg BD

5mg BD

15mg BD

Placebo BID

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 14, 2008
Last Updated
January 18, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00615199
Brief Title
A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1mg BD
Arm Type
Experimental
Arm Title
5mg BD
Arm Type
Experimental
Arm Title
15mg BD
Arm Type
Experimental
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
administration via oral route twice daily
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
administration via oral route twice daily
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
administration via oral route twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
administration via oral route twice daily
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Response 70 at Week 4
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Response 70 at Week 1 and 2
Description
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.
Time Frame
Week 1, 2
Title
Number of Participants Achieving Clinical Remission at Week 4
Description
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.
Time Frame
Week 4
Title
Number of Participants With Clinical Response 100 at Week 4
Description
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.
Time Frame
Week 4
Title
Time to First Clinical Remission
Description
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.
Time Frame
Week 1 through Week 4
Title
Time to First Response 70
Description
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.
Time Frame
Week 1 through Week 4
Title
Time to First Response 100
Description
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.
Time Frame
Week 1 through Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Pfizer Investigational Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Pfizer Investigational Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Pfizer Investigational Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33496
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Pfizer Investigational Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Pfizer Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Pfizer Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Pfizer Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Pfizer Investigational Site
City
Upper St. Clair,
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Pfizer Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8887
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Pfizer Investigational Site
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Pfizer Investigational Site
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyula
ZIP/Postal Code
5701
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Pfizer Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Pfizer Investigational Site
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
811 07
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Durbanvilee
State/Province
Cape Town
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Pfizer Investigational Site
City
L'hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24480677
Citation
Sandborn WJ, Ghosh S, Panes J, Vranic I, Wang W, Niezychowski W; Study A3921043 Investigators. A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2. doi: 10.1016/j.cgh.2014.01.029. Epub 2014 Jan 27.
Results Reference
derived
PubMed Identifier
21383241
Citation
Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921043&StudyName=A%20Study%20to%20investigate%20the%20safety%20and%20efficacy%20of%20CP-690%2C550%20in%20patients%20with%20moderate%20to%20severe%20Crohn%27s%20Disease
Description
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A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease

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