The Safety And Efficacy Of Maintenance Therapy With CP-690,550
NCT01393899
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Nashville, Tennessee
- Brussels,
- Leuven,
- Helsinki,
- Rotterdam, Zuid-Holland
- Amsterdam,
- Amsterdam,
- Breda,
- Enschede,
- Leiden,
- Nijmegen,
- Rotterdam,
- Utrecht,
- Zwolle,
- Scottsdale, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Tuscon, Arizona
- Lakewood, Colorado
- Littleton, Colorado
- Wheat Ridge, Colorado
- Wheatridge, Colorado
- Hamden, Connecticut
- Clearwater, Florida
- Clearwater, Florida
- Crystal River, Florida
- Inverness, Florida
- Inverness, Florida
- Sanford, Florida
- Decatur, Georgia
- Decatur, Georgia
- Marietta, Georgia
- Arlington Heights, Illinois
- Chicago, Illinois
- Evanston, Illinois
- Lexington, Kentucky
- Louisville, Kentucky
- Louisville, Kentucky
- Annapolis, Maryland
- Annapolis, Maryland
- Grand Rapids, Michigan
- Wyoming, Michigan
- Wyoming, Michigan
- Wyoming, Michigan
- Ypsilanti, Michigan
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma, Oklahoma
- Tulsa, Oklahoma
- Tulsa, Oklahoma
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Germantown, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Austin, Texas
- Austin, Texas
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Southlake, Texas
- Tyler, Texas
- Tyler, Texas
- Salt Lake City, Utah
- Richmond, Virginia
- Richmond, Virginia
- Concord, New South Wales
- Brisbane, Queensland
- South Brisbane, Queensland
- Box Hill, Victoria
- Clayton, Victoria
- Fitzroy, Victoria
- Bruxelles,
- Bruxelles,
- Leuven,
- Roeselare,
- Curitiba, PR
- Curitiba, PR
- Curitiba, PR
- Rio de Janeiro, RJ
- Rio de Janeiro, RJ
- São Paulo, SP
- Calgary, Alberta
- London, Ontario
- Toronto, Ontario
- Montreal, Quebec
- Hradec Kralove,
- Olomouc,
- Praha 10,
- Praha 4,
- Usti nad Labem,
- Aarhus C,
- Herlev,
- Hilleroed,
- Hvidovre,
- Koebenhavn NV,
- Koebenhavn,
- Koege,
- Paris, Cedex 12
- Lille Cedex,
- Hannover, Niedersachsen
- Hamburg,
- Kiel,
- Minden,
- Budapest,
- Debrecen,
- Szeged,
- Szekszard,
- Dublin,
- Dublin,
- Dublin,
- Dublin,
- Galway,
- Beith Vagan, Jerusalem
- Haifa,
- Jerusalem,
- Kfar Saba,
- Petah Tikva,
- Tel Aviv,
- Rozzano, Milano
- Padova,
- Roma,
- Rome,
- Milford, Auckland
- Hamilton,
- Zuerich,
- Cambridge,
- Glasgow,
- London,
- London,
- London,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | The Safety And Efficacy Of Maintenance Therapy With CP-690,550 | |||
Official Title ICMJE | 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 | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Crohn's Disease | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 180 | |||
Original Estimated Enrollment ICMJE | 90 | |||
Actual Study Completion Date ICMJE | July 2015 | |||
Actual Primary Completion Date | July 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Netherlands, South Africa, Spain, Ukraine, United States | |||
Removed Location Countries | Croatia, India | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01393899 | |||
Other Study ID Numbers ICMJE | A3921084 2011-001754-28 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |