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

Purpose

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	Intervention	Phase
Ulcerative Colitis	Drug: CP- 690 550 Other: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of Participants With Clinical Response [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
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:

Percentage of Participants With Clinical Remission [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	195
Study Start Date:	December 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787202

Show 59 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00787202 History of Changes
Other Study ID Numbers:	A3921063
Study First Received:	November 6, 2008
Results First Received:	December 4, 2012
Last Updated:	March 6, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pfizer:

treatment of ulcerative colitis; CP 690 550

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013