The Safety And Efficacy Of Maintenance Therapy With CP-690,550

NCT01393899 | Completed Phase 2 Results DMC

• 2 other identifiers: A39210842011-001754-28
• Study Type: interventional
• Target: 180
• Locations: 16 countries
• Sites: 90

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.

Conditions

Crohn's Disease

Keywords

tofacitinib; Xeljanz; CP-690,550; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26

  Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score \<150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal 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 26

Secondary Outcomes (15)

• Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20

  Weeks 4, 8, 12 and 20

• Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26

  Weeks 4, 8, 12, 20 and 26

• Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26

  Weeks 4, 8, 12, 20 and 26

• Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study

  Weeks 4, 8, 12, 20 and 26

• Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase

  Weeks 20 and 26

Study Arms (3)

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo

5mg BID

EXPERIMENTAL

Drug: CP-690,550

10mg BID

EXPERIMENTAL

Drug: CP-690,550

Interventions

Placebo DRUG

oral tablets twice daily

Placebo BID

CP-690,550 DRUG

oral tablets twice daily

5mg BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (91)

ACMG Endoscopy Center

Anaheim, California, 92801, United States

Location

ACRI - Phase I, LLC

Anaheim, California, 92801, United States

Location

Advanced Clinical Research Institute-Phase 1, LLC

Anaheim, California, 92801, United States

Location

West Coast Clinical Trials

Cypress, California, 90630, United States

Location

Alliance Clinical Research

Oceanside, California, 92056, United States

Location

Clinical Research Of The Rockies

Lafayette, Colorado, 80026, United States

Location

Gasteroenterology Consultants of Clearwater

Clearwater, Florida, 33756, United States

Location

West Coast Endoscopy Center

Clearwater, Florida, 33756, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Shands Endoscopy Center

Gainesville, Florida, 32608, United States

Location

Shands Hospital at the University of Florida

Gainesville, Florida, 32610-0214, United States

Location

Shands Medical Plaza and Cancer Center

Gainesville, Florida, 32610, United States

Location

University of Florida - College of Medicine

Gainsville, Florida, 32610, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Gulfshore Endoscopy Center (Endoscopies Only)

Naples, Florida, 34102, United States

Location

North Florida Gastroenterology Research, LLC

Orange Park, Florida, 32073, United States

Location

Internal Medicine Specialists

Orlando, Florida, 32806, United States

Location

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201, United States

Location

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, 66606, United States

Location

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, 20815, United States

Location

Metropolitan Gastroenterology Group, PC

Chevy Chase, Maryland, 20815, United States

Location

East Ann Arbor Health and Geriatrics Center

Ann Arbor, Michigan, 48109-2701, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109-5000, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Surgical Centers of Michigan

Troy, Michigan, 48098, United States

Location

NYU Langone Nassau Gastroenterology Associates

Great Neck, New York, 11021, United States

Location

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, New York, 12601, United States

Location

Investigational Drug Services - University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Digestive Health Specialists of Tyler

Tyler, Texas, 75701, United States

Location

Endoscopy Center of Tyler

Tyler, Texas, 75701, United States

Location

University of Utah HSC

Salt Lake City, Utah, 84132, United States

Location

Cardiology Consultants

Norfolk, Virginia, 23502, United States

Location

Digestive & Liver Desease Specialists

Norfolk, Virginia, 23502, United States

Location

Metropolitan Gastroenterology Group, P C

Washington DC, Virginia, 20006, United States

Location

The Center for Digestive Health

Milwaukee, Wisconsin, 53215, United States

Location

Wisconsin Center for Advanced Research - GI Associates, LLC

Milwaukee, Wisconsin, 53215, United States

Location

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226, United States

Location

GI Associates

Wauwatosa, Wisconsin, 53226, United States

Location

Nepean Public Hospital

Kingswood, New South Wales, 2747, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Royal Melbourne Hospital

Melbourne, 3050, Australia

Location

AKH Wien Universitaetsklinik fuer Innere Medizin III

Vienna, 1090, Austria

Location

4 MBAL Parvo vatreshno otdelenie

Sofia, 1000, Bulgaria

Location

MBAL Sofiamed OOD, Otdelenie po gastroenterologia

Sofia, 1797, Bulgaria

Location

Office of Dr. David C. Pearson

Victoria, British Columbia, V8R 6R3, Canada

Location

Office of Drs. Ranjith Andrew Singh and Jamie D. Papp,

Victoria, British Columbia, V8V 3P9, Canada

Location

PerCuro Clinical Research Ltd.

Victoria, British Columbia, V8V 3P9, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Montreal General Hospital - McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 50012, Czechia

Location

Medial Pharma spol.s.r.o. (Pharmacy only)

Hradec Králové, 50012, Czechia

Location

RDG centrum s.r.o. (Radiology only)

Hradec Králové, 50012, Czechia

Location

Hopital Huriez CHRU de Lille

Lille, 59037, France

Location

Hôpital Haut-Lévêque/Service d hépato-gastroentérologie

Pessac, 33064, France

Location

Charite - Campus Berlin Mitte

Berlin, 10117, Germany

Location

Charite - Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I

Ulm, 89081, Germany

Location

General Hospital of Athens "Evangelismos",1st Gastroenterology Department

Kolonaki Athens, 106 76, Greece

Location

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia

Budapest, 1125, Hungary

Location

Pannonia Magánorvosi Centrum Kft

Budapest, 1136, Hungary

Location

Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium

Budapest, H-1044, Hungary

Location

Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

Budapest, H-1076, Hungary

Location

Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,

Gyöngyös, 3200, Hungary

Location

Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium

Kaposvár, H-7400, Hungary

Location

Clinfan Kft.

Szekszárd, 7100, Hungary

Location

Digestive Disease Institute

Jerusalem, 91031, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64932, Israel

Location

The Hospital of Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

Location

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, 983-8520, Japan

Location

Osaka City University Hospital

Osaka, Osaka, 545-8586, Japan

Location

Toho University Sakura Medical Center

Chiba, 285-8741, Japan

Location

Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

Hokkaido, 060-0033, Japan

Location

VU University Medical Center

Amsterdam, 1081HV, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Kingsbury Hospital

Cape Town, Western Cape, 7708, South Africa

Location

Parklands Medical Centre

Durban, 4091, South Africa

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine

Seoul, 135-710, South Korea

Location

ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine

Seoul, 138-736, South Korea

Location

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Comite Etico de Investigacion Clinica

Barcelona, 08036, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2

Donetsk, 83017, Ukraine

Location

Municipal Institution "Odesa Regional Clinical Hospital", Odesa Regional Centre of Gastroenterology.

Odesa, 65117, Ukraine

Location

Medical Clinical Research Center of Medical Center "Health Clinic" LLC

Vinnitsa, 21029, Ukraine

Location

Related Publications (1)

• Panes 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.

  PMID: 28209624 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: LTE60
• 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: July 12, 2011
• First Posted: July 13, 2011
• Study Start: March 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Locations

ZA (2); JP (5); NL (2); CZ (3); FR (2); CA (5); US (41); BU (2); AU (3); GR (1); DE (5); UA (3); IL (3); KR (3); ES (3); HU (7)