A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT

Pfizer Inc.0 sites357 target enrollmentSeptember 5, 2012

ConditionsCrohn’s Disease (CD) and Ulcerative Colitis (UC)MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Crohn’s Disease (CD) and Ulcerative Colitis (UC)
Sponsor: Pfizer Inc.
Enrollment: 357
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 5, 2012

End Date

February 4, 2016

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Pfizer Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
•2\. Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
•3\. Male and/or female subjects between the ages of \=18 and \=65 years at the time of informed consent.
•4\. A diagnosis of UC for \=3 months. A biopsy report must be available to confirm the histological diagnosis in the subject’s source documentation. In addition, a report documenting disease duration and extent of disease (e.g., proctosigmoiditis, left\-sided colitis and pancolitis) based upon prior colonoscopy must also be available in source documentation. NOTE: A colonoscopy with biopsy will need to be performed, if this documentation is not available.
•5\. Must have a flexible sigmoidoscopy (or colonoscopy, if preferred) indicative of active UC (Mayo endoscopic subscore of at least 2\) during screening after all other inclusion criteria have been met.
•6\. Must have active disease beyond the rectum (\>15 cm of active disease at the Screening endoscopy).
•7\. Must have active UC with a Total Mayo Score of 6 to 12 points and moderate to severe disease on endoscopy (Mayo endoscopic subscore of at least 2\).
•8\. Must have failed or been intolerant of at least one conventional therapy such as mesalamine, steroids and immunosuppressants (AZA, 6\-MP or MTX) or anti\-TNF. Subjects will be stratified based upon prior experience with anti\-TNFs (naïve or experienced). Documentation of the current and prior UC treatment (ie, steroids and immunosuppressants) will be captured for additional analyses and must be provided in the source documentation.
•9\. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception (defined at the time of signing the informed consent) throughout the study and through the conclusion of subject participation. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
•Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline. WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.

Exclusion Criteria

•1\. Subjects with a diagnosis of indeterminate colitis or Crohn’s disease. Subjects with clinical findings suggestive of Crohn’s disease, e.g., fistulae or granulomas on biopsy are also excluded.
•2\. Subjects with an imminent need for or planned surgery.
•3\. Subjects with colonic dysplasia or neoplasia.
•4\. Subjects with toxic megacolon.
•5\. Subjects with primary sclerosing cholangitis.
•6\. Subjects with known colonic stricture.
•7\. Subjects with a history of colonic or small bowel obstruction or resection.
•8\. Abnormal findings on the chest x\-ray film performed routinely before initiating a new biologic therapy, such as presence of tuberculosis (TB), general infections, heart failure, or malignancy. (Chest x\-ray examination may be performed up to 12 weeks prior to study entry (screening). Documentation of the official reading must be located and available in the source documentation).
•9\. Any history or current evidence of latent or active tuberculosis infection, evidence of prior or currently active tuberculosis by chest radiography, residing with or frequent close contact with individual(s) with active tuberculosis. Subjects who have a positive Mantoux (PPD) tuberculin skin test or a positive Interferon Gamma Release Assay (IGRA to be tested at the site’s local lab) during screening or within 12 weeks prior to randomization. The following are acceptable assays: QuantiFERON® \- TB Gold test (QFT\-G), QuantiFERON® \- TB Gold In\-Tube test (QFT\-GIT) and T\-SPOT®\-TB test) during screening or within 12 weeks prior to screening.
•10\. Presence of active enteric infections (positive stool culture and sensitivity).