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

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ClinicalTrials.gov Identifier: NCT00787202
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 6, 2008
First Posted Date  ICMJE November 7, 2008
Results First Submitted Date  ICMJE December 4, 2012
Results First Posted Date  ICMJE April 16, 2013
Last Update Posted Date April 16, 2013
Study Start Date  ICMJE December 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
Clinical response at Week 8 (decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1). [ Time Frame: at Week 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
  • Clinical remission (total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point). [ Time Frame: at Week 8 ]
  • Endoscopic response (decrease from baseline of at least one point in the Mayo endoscopic subscore) [ Time Frame: at Week 8 ]
  • Change from baseline in fecal calprotectin [ Time Frame: at Day 1, Week 2, Week 4, Week 8 and Week 12 ]
  • Incidence and severity of adverse events. [ Time Frame: at Day 1, Week 2, Week 4, Week 8 and Week 12 ]
  • Endoscopic remission (Mayo endoscopic subscore equals 0). [ Time Frame: at Week 8 ]
  • Improvement in quality of life measured by IBDQ [ Time Frame: at Week 8 ]
  • Change from baseline in CRP [ Time Frame: at Day 1, Week 4 and Week 8 ]
  • Incidence and severity of clinical laboratory abnormalities [ Time Frame: at Day 1, Week 2, Week 4, Week 8 and Week 12 ]
  • Pharmacokinetics of CP-690,550, its correlation with clinical response and inflammatory biomarkers. [ Time Frame: at Day 1 , Week 2, Week 4 and Week 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: CP- 690 550
    Administration via oral route twice daily for the duration of treatment
  • Other: placebo
    Administration via oral route twice daily for the duration of treatment
Study Arms  ICMJE
  • Experimental: 15 mg BID
    Intervention: Drug: CP- 690 550
  • Experimental: 10 mg BID
    Intervention: Drug: CP- 690 550
  • Experimental: 3 mg BID
    Intervention: Drug: CP- 690 550
  • Experimental: 0.5 mg BID
    Intervention: Drug: CP- 690 550
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
195
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2008)
192
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Chile,   Czech Republic,   Denmark,   France,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT00787202
Other Study ID Numbers  ICMJE A3921063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP