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COMPLETED Phase 3

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

NCT01458951 · View on ClinicalTrials.gov ↗

Study Summary

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG tofacitinib

Study Locations (20)

California

  • Alliance Clinical Research — Oceanside
  • Clinical Application Laboratories — San Diego
  • San Diego Endoscopy Center — San Diego
  • UCSF Endoscopy Unit at Mount Zion — San Francisco
  • University of California San Francisco — San Francisco
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance

Florida

  • Citrus Surgery & Endoscopy Center (Colonoscopy) — Crystal River
  • Nature Coast Clinical Research — Inverness
  • Suncoast Endoscopy Center (colonoscopy) — Inverness
  • Gastroenterology Group of Naples — Naples
  • Advanced Gastroenterology Center — Port Orange
  • Advanced Medical Research Center — Port Orange

Connecticut

  • Bristol Hospital — Bristol
  • Connecticut Clinical Research Foundation — Bristol
  • Yale New Haven Hospital — New Haven
  • Yale University School of Medicine — New Haven
  • Central Connecticut Endoscopy Center — Plainville

Arizona

  • Desert Sun Clinical Research, LLC — Tucson
  • Desert Sun Gastroenterology — Tucson
  • Desert Sun Surgery Center — Tucson

Trial Details

FieldValue
Enrollment Target 547 participants
Start Date 2012-06
Est. Completion 2015-06
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01458951

The ClinicalTrials.gov registry entry for NCT01458951 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01458951 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01458951 about?

NCT01458951 is a clinical study titled "A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis". This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha thera...

What is the current status of trial NCT01458951?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2012-06. Estimated completion is 2015-06.

What conditions does trial NCT01458951 study?

This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01458951?

The interventions under investigation include: Placebo (DRUG), tofacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01458951?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01458951 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial