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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: CP- 690 550 Other: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/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
Placebo Comparator: Placebo Other: placebo
Administration via oral route twice daily for the duration of treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787202


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00787202    
Other Study ID Numbers: A3921063
First Posted: November 7, 2008    Key Record Dates
Results First Posted: April 16, 2013
Last Update Posted: April 16, 2013
Last Verified: March 2013
Keywords provided by Pfizer:
treatment of ulcerative colitis; CP 690 550
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases