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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00787202
First received: November 6, 2008
Last updated: March 6, 2013
Last verified: March 2013

November 6, 2008
March 6, 2013
December 2008
September 2010   (final data collection date for primary outcome measure)
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).
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00787202 on ClinicalTrials.gov Archive Site
  • 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.
  • Clinical remission (total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point). [ Time Frame: at Week 8 ] [ Designated as safety issue: No ]
  • Endoscopic response (decrease from baseline of at least one point in the Mayo endoscopic subscore) [ Time Frame: at Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in fecal calprotectin [ Time Frame: at Day 1, Week 2, Week 4, Week 8 and Week 12 ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events. [ Time Frame: at Day 1, Week 2, Week 4, Week 8 and Week 12 ] [ Designated as safety issue: Yes ]
  • Endoscopic remission (Mayo endoscopic subscore equals 0). [ Time Frame: at Week 8 ] [ Designated as safety issue: No ]
  • Improvement in quality of life measured by IBDQ [ Time Frame: at Week 8 ] [ Designated as safety issue: No ]
  • Change from baseline in CRP [ Time Frame: at Day 1, Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Incidence and severity of clinical laboratory abnormalities [ Time Frame: at Day 1, Week 2, Week 4, Week 8 and Week 12 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
  • 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
  • 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
Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Belgium,   Brazil,   Chile,   Czech Republic,   United Kingdom,   France,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Slovakia,   South Africa,   Spain,   Sweden
 
NCT00787202
A3921063
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

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