Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)

Conditions: moderately to severely active Ulcerative Colitis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
MedDRA version: 14.1Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders

Registration Number: EUCTR2006-002670-22-IT

Lead Sponsor: SCHERING-PLOUGH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

adult patients > 21 years old with moderately to severely active UC with a Mayo score of 6 to 12 points inclusive ? endoscopic evidence of disease ? are on a stable dose of not more than 30 mg per day corticosteroid for at least 3 months ? are naïve to Infliximab ? patients who are either naïve to Azathioprine or did not receive Azathioprine or other immunomodulators for at least 3 months before entering the study ? patients who did not have AEs and did not show intolerance to Azathioprine or 6-MP
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Investigator judgment that the subject is likely to require colectomy within 12 weeks of Baseline OR b. Subject symptom complex at Screening or Baseline visits, as follows: diarrhea with ≥6 bowel movements/day with macroscopic blood in stool; persistent fever (≥37.5°C) for at least 3 days prior to baseline; 4) tachycardia (>100 beats/minute); 5) anemia (8.5 g/dL). 2. Require, or required within the 2 months prior to baseline, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage or other conditions possibly confounding the evaluation of disease activity; 3. Have severe, fixed symptomatic stenosis of the large or small intestine; 4. Have current evidence of colonic obstruction or history within the 6 months prior to baseline, confirmed with objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy); 5. Have a history of colonic mucosal dysplasia; 6. Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed; 7. Presence of a stoma; 8. Have a history of extensive colonic resection that would prevent adequate evaluation of clinical disease activity (eg, less than 30 cm of colon remaining); 9. Have a positive stool culture for enteric pathogens, pathogenic ova or parasites within 4 months prior to Baseline unless subject has received treatment and had a negative stool examination 1 week or longer after the end of treatment; 10. Have a concomitant diagnosis of congestive heart failure (CHF), including medically controlled asymptomatic subjects; 11. Have had serious infections (eg, active hepatitis, pneumonia, or pyelonephritis) within 2 months of screening. Less serious infections (such as acute upper respiratory tract infection [colds] or a simple urinary tract infection) need not be considered as an exclusion at the discretion of the investigator; 12. Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to Screening; 13. Have a known infection with human immunodeficiency virus (HIV) and/or hepatitis B or hepatitis C; 14. Have a history of a known allergy to murine proteins or allergy/sensitivity to study drug or its excipients; 15. Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases; 16. Have a known history of demyelinating disease suggestive of multiple sclerosis or optic neuritis; 17. Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening); 18. Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly; 19. Have any current known malignancy or malignancy within 5 years prior to screening (except for squamous or basal cell carcinoma of