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

NCT00615199 | Completed Phase 2 Results

• 1 other identifier: A3921043
• Study Type: interventional
• Target: 139
• Locations: 12 countries
• Sites: 72

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).

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Participants With Clinical Response 70 at Week 1 and 2

  Week 1, 2

• Number of Participants Achieving Clinical Remission at Week 4

  Week 4

• Number of Participants With Clinical Response 100 at Week 4

  Week 4

• Time to First Clinical Remission

  Week 1 through Week 4

• Time to First Response 70

  Week 1 through Week 4

Study Arms (4)

1mg BD

EXPERIMENTAL

Drug: CP-690,550

5mg BD

EXPERIMENTAL

Drug: CP-690,550

15mg BD

EXPERIMENTAL

Drug: CP-690,550

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CP-690,550 DRUG

administration via oral route twice daily

1mg BD

Placebo DRUG

administration via oral route twice daily

Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects currently receiving immunosuppressants, interferon, anti-TNFa
• Subjects with evidence of hematopoietic disorders
• Subjects with evidence of active or latent TB

Sponsors & Collaborators

• Pfizer: lead

Study Sites (72)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Mobile, Alabama, 36617, United States

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Boulder, Colorado, 80304, United States

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Lakewood, Colorado, 80215, United States

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Wheat Ridge, Colorado, 80033, United States

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Washington D.C., District of Columbia, 20006, United States

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Boca Raton, Florida, 33428, United States

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Boca Raton, Florida, 33442, United States

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Boca Raton, Florida, 33486, United States

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Boca Raton, Florida, 33496, United States

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Gainesville, Florida, 32605, United States

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Gainesville, Florida, 32607, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32256, United States

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St. Petersburg, Florida, 33709, United States

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Chicago, Illinois, 60637, United States

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Wichita, Kansas, 67208, United States

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Louisville, Kentucky, 40202, United States

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Chevy Chase, Maryland, 20815, United States

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Towson, Maryland, 21204, United States

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Troy, Michigan, 48098, United States

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Rochester, Minnesota, 55905, United States

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Mexico, Missouri, 65265, United States

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Great Neck, New York, 11021, United States

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Charlotte, North Carolina, 28209, United States

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Charlotte, North Carolina, 28210, United States

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Charlotte, North Carolina, 28211, United States

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Salisbury, North Carolina, 28144, United States

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Dayton, Ohio, 45415, United States

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Duncansville, Pennsylvania, 16635, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Upper Saint Clair, Pennsylvania, 15241, United States

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Bristol, Tennessee, 37620, United States

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Kingsport, Tennessee, 37660, United States

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Nashville, Tennessee, 37205, United States

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Dallas, Texas, 75235, United States

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Dallas, Texas, 75390-8887, United States

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Seattle, Washington, 98195, United States

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Charleston, West Virginia, 25304, United States

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Hradec Králové, 50012, Czechia

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Ústí nad Labem, 401 13, Czechia

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Vandœuvre-lès-Nancy, France, 54511, France

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Lille, 59037, France

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Pessac, 33604, France

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Békéscsaba, 5600, Hungary

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Debrecen, 4004, Hungary

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Győr, 9023, Hungary

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Gyula, 5701, Hungary

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Kaposvár, 7400, Hungary

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Szekszárd, 7100, Hungary

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Bologna, 40138, Italy

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Roma, 00152, Italy

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Amsterdam, 1105 AZ, Netherlands

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Lublin, 20-954, Poland

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Olsztyn, 10-561, Poland

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Wroclaw, 50-556, Poland

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Bratislava, Slovakia, 826 06, Slovakia

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Bratislava, 811 07, Slovakia

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Nitra, 94901, Slovakia

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Durbanvilee, Cape Town, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Durban, South Africa, 4091, South Africa

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Cape Town, Western Cape, 7708, South Africa

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Barcelona, Barcelona, 08036, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Majadahonda, Madrid, 28922, Spain

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Bristol, BS2 8HW, United Kingdom

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Salford, M6 8HD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24480677 DERIVED

• 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.

  PMID: 21383241 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Crohn Disease

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: February 14, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 25, 2013
• Results First Posted: December 31, 2012

Record last verified: 2013-01

Locations

BE (3); ES (3); HU (6); IT (2); NL (1); ZA (5); CZ (2); SL (3); US (39); FR (3); GB (2); PL (3)