A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

NCT01470599 | Completed Phase 2 Results DMC

• 2 other identifiers: A39210862011-003622-27
• Study Type: interventional
• Target: 150
• Locations: 16 countries
• Sites: 74

Brief Summary

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (6)

• Adjudicated Potential Cardiovascular Events

  Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium 'Standardized Definitions for End Point Events in Cardiovascular Trials' published October 2010.

  From baseline to Week 52

• Adjudicated Malignancy Events

  Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.

  From baseline to Week 52

• Adjudicated Hepatic Injury Events

  Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor \& search of clinical, safety \& laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy's law case, recovery \& liver failure (all yes, no or undetermined).

  From baseline to Week 52

• Adjudicated Opportunistic Infection Events

  Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor \& search of SAE listings for serious infections coded to MedDRA infections \& infestations SOC \&/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research \& Treatment of Cancer/Invasive Fungal Infections Cooperative Group \& the National Institute of Allergy \& Infectious Diseases Mycoses Study Group \[EORTC/MSG\] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial \& parasitic infections \& vaccine dissemination) \& special interest infections (actinomycosis, Legionella \& mononucleosis-like toxoplasmosis).

  From baseline to Week 52

• Adjudicated Gastrointestinal (GI) Perforation Events

  Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.

  From baseline to Week 52

• Adjudicated Interstitial Lung Disease (ILD) Events

  Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety \& laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).

  From baseline to Week 52

Secondary Outcomes (23)

• Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48

  Week 48

• Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study

  Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

• Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study

  Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

• Time to Relapse Among Participants in Clinical Remission at Baseline

  From baseline to Week 52

• Observed CDAI Score by Week

  Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

Study Arms (2)

5mg BID

EXPERIMENTAL

Drug: CP-690,550

10mg BID

EXPERIMENTAL

Drug: CP-690,550

Interventions

CP-690,550 DRUG

ORAL TABLET, TWICE DAILY

5mg BID

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
• Women of childbearing potential must test negative for pregnancy prior to study enrolment.
• Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

You may not qualify if:

• Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
• Subjects who were discontinued from the A3921084 study due to an adverse event.
• Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (75)

Alliance Clinical Research

Oceanside, California, 92056, United States

Location

Clinical Research Of The Rockies

Lafayette, Colorado, 80026, United States

Location

Gastroenterology 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

Investigational Drug Service

Gainesville, Florida, 32610, United States

Location

Shands Medical Plaza and Cancer Center

Gainesville, 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

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 Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

NYU Langone Nassau Gastroenterology Associates

Great Neck, New York, 11021, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

The Endoscopy Center of Lake County

Mentor, Ohio, 44060, United States

Location

Great Lakes Gastroenterology

Willoughby, Ohio, 44094, United States

Location

Christus Trinity Mother Frances Endoscopy Center

Tyler, Texas, 75701, 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

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, 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

Parkville, Victoria, 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, Jamie D. Papp

Victoria, British Columbia, V8V 3P9, Canada

Location

PerCuro Clinical Research Limited

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, H3G 1A4, Canada

Location

Medial Pharma spol.s.r.o.

Hradec Králové, 500 12, Czechia

Location

RDG centrum s.r.o.

Hradec Králové, 500 12, Czechia

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 50012, Czechia

Location

Hopital Huriez - CHRU de Lille

Lille, 59037, France

Location

Hôpital Haut-Lévêque

Pessac, 33604, France

Location

Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

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

Kolonaki Athens, 106 76, Greece

Location

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

Budapest, 1076, Hungary

Location

Pannonia Magánorvosi Centrum Kft

Budapest, 1136, Hungary

Location

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, H-1125, Hungary

Location

Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,

Gyöngyös, 3200, Hungary

Location

Clinfan Kft.

Szekszárd, 7100, Hungary

Location

Department of medicine Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Dept. of Gastroenterology & Hepatology, Meir Medical Center

Kfar Saba, 44281, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

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

Sapporo, Hokkaido, 060-0033, Japan

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

Toho University Sakura Medical Center

Chiba, 285-8741, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Parklands Medical Centre

Durban, 4091, South Africa

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Soeul, 138-736, South Korea

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2

Madrid, 28222, Spain

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, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.

  PMID: 30663107 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 11, 2011
• Study Start: April 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 16, 2017
• Results First Posted: October 16, 2017

Record last verified: 2017-09

Locations

ZA (1); NL (2); UA (2); CZ (3); HU (5); US (32); DE (3); AU (3); GR (1); JP (5); CA (5); ES (3); FR (2); IL (3); BU (2); KR (2)