A Study of Abatacept in Patients With Active Ulcerative Colitis - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00410410

Purpose

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

Condition	Intervention	Phase
Ulcerative Colitis	Drug: abatacept Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Compare proportion of subjects in response (reduction from baseline in Mayo score ≥ 3 pts and ≥ 30%, also with decrease from baseline in rectal bleeding subscore ≥ 1 pt or absolute rectal bleeding subscore ≤ 1 pt) at Wk 12 between abatacept and placebo [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Compare proportion of subjects in response (reduction from baseline in Mayo score ≥3 pts and ≥30%, also with decrease from baseline in rectal bleeding subscore ≥1 pt or absolute rectal bleeding subscore of ≤1) at Month 12 between abatacept and placebo [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Assess the long-term clinical safety and tolerability of abatacept treatment during the Open-Label Extension Phase [ Time Frame: during the open-label treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compare the proportion of subjects in clinical remission (defined as Mayo score ≤ 2 points and no individual subscore exceeding 1 point) at Week 12 between the abatacept and placebo treatment regimens [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Compare the proportion of subjects with mucosal healing (defined as endoscopic subscore ≤ 1 point) at Week 12 between the abatacept and placebo treatment regimens [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Evaluate the dose-response relationship by comparing the proportions of subjects in clinical response at Week 12 induced by placebo and abatacept in increasing doses (3 mg/kg, ~10 mg/kg, 30/~10 mg/kg) [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Assess in abatacept vs placebo treated subjects improvements in quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score at Week 12 [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Assess the proportion of abatacept vs placebo treated subjects with Mayo subscores (rectal bleeding, stool frequency, physician's global assessment) indicative of mild disease (individual subscore ≤ 1) at Week 12 [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Evaluate in subjects with inadequate response and/or intolerance to anti TNFs, the dose-response relationship by comparing the proportions of subjects in clinical response at Wk 12 induced by placebo and abatacept in increasing doses (3,~10, 30/~10mg/kg) [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Assess in abatacept vs placebo treated subjects who have had an inadequate response and/or intolerance to anti-TNF therapy, a) the proportion in clinical response, b) the proportion in remission, and c) the proportion with mucosal healing at Weeks 12 [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Assess the immunogenicity of abatacept in subjects with UC [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: No ]
Assess the tolerability and safety of abatacept in subjects with UC [ Time Frame: after 12 weeks of Induction therapy ] [ Designated as safety issue: Yes ]
Compare the proportion of subjects who are in clinical remission (defined as a Mayo score ≤ 2 points and no individual subscore exceeding 1 point) at Month 12 between the abatacept and placebo treatment regimens [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Compare the proportion of subjects with mucosal healing (defined as endoscopic subscore ≤ 1) at Month 12 between the abatacept and placebo treatment regimens [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Compare the proportion of subjects who are in clinical remission at both Month 6 (Day MP-169) and Month 12 between the abatacept and placebo treatment regimens [ Time Frame: after 12 weeks of Induction therapy and a subsequent 6 months and 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Compare the proportion of subjects using oral corticosteroids at baseline who have discontinued corticosteroids and are in remission at Month 12 between the abatacept and placebo treatment regimens [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Assess in abatacept vs placebo treated subjects improvements in quality of life as measured by a) the IBDQ score and b) the Short Form-36 (SF-36) at Month 12 [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Assess the proportion of abatacept versus placebo treated subjects using oral corticosteroids at baseline who have discontinued corticosteroids for at least 90 consecutive days and are in remission at Month 12 [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Assess the proportion of abatacept versus placebo treated subjects with Mayo subscores (rectal bleeding, stool frequency, physician's global assessment) indicative of mild disease (individual subscore ≤ 1) at Month 12 [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Assess in abatacept versus placebo treated-subjects who have had an inadequate response and/or intolerance to anti-TNF therapy a) the proportion in clinical response, b) the proportion in remission, and c) the proportion with mucosal healing at Month 12 [ Time Frame: after 12 weeks of Induction therapy and a subsequent 12 months of maintenance therapy ] [ Designated as safety issue: No ]
Assess the immunogenicity of abatacept in subjects with UC [ Time Frame: during the 12 week double-blind induction treatment period and during the subsequent 12 month double-blind maintenance treatment period ] [ Designated as safety issue: No ]
Assess the tolerability and safety of abatacept in subjects with UC [ Time Frame: during the 12 week double-blind induction treatment period and during the subsequent 12 month double-blind maintenance treatment period ] [ Designated as safety issue: Yes ]
Assess durability of clinical efficacy (clinical response and remission), clinical efficacy upon retreatment, immunogenicity, and corticosteroid use [ Time Frame: during the open-label treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	636
Study Start Date:	December 2006
Study Completion Date:	November 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 4 arms for induction period 2 arms for maintenance period	Drug: abatacept D5W, IV, 0, 3, ~10, 30 mg/kg, once monthly Induction Period 3 months Maintenance Period 12 months
2: Placebo Comparator 4 arms for induction period 2 arms for maintenance period	Drug: placebo NS, IV, ~10 mg/kg, once monthly Induction Period 3 months Maintenance Period 12 months
abatacept 1 arm for open-label extension phase	Drug: abatacept ~10 mg/kg, once monthly Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women 18 years or older
Ulcerative colitis for at lease 3 months
Moderate to severe active ulcerative colitis
Inadequate response or intolerance to standard ulcerative colitis treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410410

Show 144 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-108
Study First Received:	December 11, 2006
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00410410 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Immunologic Factors
Gastrointestinal Diseases
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Immunosuppressive Agents

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Abatacept
Therapeutic Uses
Gastroenteritis
Antirheumatic Agents
Colitis

ClinicalTrials.gov processed this record on February 08, 2010