A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

March 6, 2013 updated by: Pfizer

A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.

The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 01244-030
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 05651-901
        • Pfizer Investigational Site
  • Chile
      • Vina del Mar, Chile, 2570017
        • Pfizer Investigational Site
    • Santiago
      • Independencia, Santiago, Chile, 8380418
        • Pfizer Investigational Site
    • Santiago RM
      • Independencia, Santiago RM, Chile, 8380456
        • Pfizer Investigational Site
  • Czech Republic
      • Hradec Kralove, Czech Republic, 50012
        • Pfizer Investigational Site
      • Olomouc, Czech Republic, 775 20
        • Pfizer Investigational Site
      • Usti n. Labem, Czech Republic, 401 13
        • Pfizer Investigational Site
      • Usti nad Labem, Czech Republic, 401 13
        • Pfizer Investigational Site
  • Denmark
      • Aalborg, Denmark, 9100
        • Pfizer Investigational Site
      • Aarhus C, Denmark, 8000
        • Pfizer Investigational Site
  • France
      • Bordeaux cedex, France, 33075
        • Pfizer Investigational Site
      • Lille Cedex, France, 59037
        • Pfizer Investigational Site
      • Marseille cedex 20, France, 13915
        • Pfizer Investigational Site
      • Nantes CEDEX 1, France, 44093
        • Pfizer Investigational Site
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Pfizer Investigational Site
      • Budapest, Hungary, 1125
        • Pfizer Investigational Site
      • Budapest, Hungary, 1135
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4004
        • Pfizer Investigational Site
      • Gyor, Hungary, 9023
        • Pfizer Investigational Site
      • Gyula, Hungary, 5701
        • Pfizer Investigational Site
      • Kaposvar, Hungary, 7400
        • Pfizer Investigational Site
      • Miskolc, Hungary, 3529
        • Pfizer Investigational Site
      • Mosonmagyarovar, Hungary, 9200
        • Pfizer Investigational Site
      • Szeged, Hungary, 6720
        • Pfizer Investigational Site
      • Szekszard, Hungary, 7100
        • Pfizer Investigational Site
      • Szentes, Hungary, 6600
        • Pfizer Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • Pfizer Investigational Site
      • Petah-tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel Aviv, Israel, 64239
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Roma, Italy, 00152
        • Pfizer Investigational Site
  • Mexico
    • Mexico DF
      • Delegacion Benito Juarez, Mexico DF, Mexico, 03300
        • Pfizer Investigational Site
      • Tlalpan, Mexico DF, Mexico, 14000
        • Pfizer Investigational Site
  • Netherlands
    • NH
      • Amsterdam, NH, Netherlands, 1081 HV
        • Pfizer Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Pfizer Investigational Site
      • Lodz, Poland, 90-153
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-556
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 811 07
        • Pfizer Investigational Site
      • Nitra, Slovakia, 94901
        • Pfizer Investigational Site
  • South Africa
    • Durban
      • Overport, Durban, South Africa, 4091
        • Pfizer Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Pfizer Investigational Site
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4001
        • Pfizer Investigational Site
    • Western Cape
      • Claremont, Western Cape, South Africa, 7708
        • Pfizer Investigational Site
      • Durbanville, Western Cape, South Africa, 7550
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Pfizer Investigational Site
  • Sweden
      • Umea, Sweden, 901 85
        • Pfizer Investigational Site
      • Vaxjo, Sweden, 351 85
        • Pfizer Investigational Site
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G11 6NT
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G4 0SS
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be at least 18 years of age at screening
  • Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
  • Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
  • Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

  • Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
  • Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
  • Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: placebo
Administration via oral route twice daily for the duration of treatment
EXPERIMENTAL: 15 mg BID
Drug: CP- 690 550
Administration via oral route twice daily for the duration of treatment
EXPERIMENTAL: 10 mg BID
Drug: CP- 690 550
Administration via oral route twice daily for the duration of treatment
EXPERIMENTAL: 3 mg BID
Drug: CP- 690 550
Administration via oral route twice daily for the duration of treatment
EXPERIMENTAL: 0.5 mg BID
Drug: CP- 690 550
Administration via oral route twice daily for the duration of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Response
Time Frame: Week 8
Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Remission
Time Frame: Week 8
Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
Week 8
Percentage of Participants With Endoscopic Response
Time Frame: Week 8
Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
Week 8
Percentage of Participants With Endoscopic Remission
Time Frame: Week 8
Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
Week 8
Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12
Time Frame: Baseline, Week 2, 4, 8, 12
Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
Baseline, Week 2, 4, 8, 12
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Time Frame: Baseline, Week 8
IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.
Baseline, Week 8
Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8
Time Frame: Baseline, Week 4, 8
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline, Week 4, 8
Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12
Time Frame: Baseline, Week 2, 4, 8, 12
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Baseline, Week 2, 4, 8, 12
Plasma Concentration of CP-690,550
Time Frame: 0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8
Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter [ng/mL]) to zero.
0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

November 6, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (ESTIMATE)

November 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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