Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis
Brief Summary: * PHASE: II
* TYPE OF STUDY : With direct benefit
* DESCRIPTIVE: Multicenter, randomized, double-blind study
* INCLUSION CRITERIA: Steroid-dependent ulcerative colitis
* OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis
* STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week
* NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients
* INCLUSION PERIOD: 24 months
* STUDY DURATION: 36 months
* EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.


Options:
A: Intervention Type: DRUG; Name: SPD476 (mesalazine); Assigned to Arm(s): N/A
B: Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: methotrexate | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
C: Arm Label: 0.03 mg/kg or placebo iv; Type: OTHER; Interventions: Biological: Single dose-group A | Arm Label: 0.1 mg/kg or placebo iv; Type: OTHER; Interventions: Biological: Single dose-group A, Biological: Multiple dose- Group B | Arm Label: 0.3 mg/kg or placebo iv; Type: OTHER; Interventions: Biological: Single dose-group A, Biological: Multiple dose- Group B | Arm Label: 1.0 mg/kg or placebo iv; Type: EXPERIMENTAL; Interventions: Biological: Single dose-group A | Arm Label: 3.0 mg/kg or placebo sc; Type: OTHER; Interventions: Biological: Single dose-group A | Arm Label: 10 mg/kg or placebo iv; Type: OTHER; Interventions: Biological: Single dose-group A | Arm Label: 0.3 mg/kg or placebo sc; Type: OTHER; Interventions: Biological: Single dose-group A, Biological: Multiple dose-Group B | Arm Label: 0.1 mg/kg or placebo iv (multiple dose); Type: OTHER; Interventions: Biological: Multiple dose- Group B | Arm Label: 0.3 mg/kg or placebo iv (multiple dose); Type: OTHER; Interventions: Biological: Multiple dose- Group B | Arm Label: 3.0 mg/kg or placebo iv; Type: OTHER; Interventions: Biological: Multiple dose- Group B | Arm Label: 0.1 mg/kg or placebo sc; Type: OTHER; Interventions: Biological: Multiple dose- Group B | Arm Label: 0.3 mg/kg or placebo sc (multiple dose); Type: OTHER; Interventions: Biological: Multiple dose-Group B | Intervention Type: BIOLOGICAL; Name: Single dose-group A; Assigned to Arm(s): 0.03 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Single dose-group A; Assigned to Arm(s): 0.1 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Multiple dose- Group B; Assigned to Arm(s): 0.1 mg/kg or placebo iv (multiple dose) | Intervention Type: BIOLOGICAL; Name: Single dose-group A; Assigned to Arm(s): 0.3 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Multiple dose- Group B; Assigned to Arm(s): 0.3 mg/kg or placebo iv (multiple dose) | Intervention Type: BIOLOGICAL; Name: Single dose-group A; Assigned to Arm(s): 1.0 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Single dose-group A; Assigned to Arm(s): 3.0 mg/kg or placebo sc | Intervention Type: BIOLOGICAL; Name: Single dose-group A; Assigned to Arm(s): 10 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Single dose-group A; Assigned to Arm(s): 0.3 mg/kg or placebo sc | Intervention Type: BIOLOGICAL; Name: Multiple dose-Group B; Assigned to Arm(s): 0.3 mg/kg or placebo sc | Intervention Type: BIOLOGICAL; Name: Multiple dose- Group B; Assigned to Arm(s): 0.1 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Multiple dose- Group B; Assigned to Arm(s): 0.3 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Multiple dose- Group B; Assigned to Arm(s): 3.0 mg/kg or placebo iv | Intervention Type: BIOLOGICAL; Name: Multiple dose- Group B; Assigned to Arm(s): 0.1 mg/kg or placebo sc | Intervention Type: BIOLOGICAL; Name: Multiple dose-Group B; Assigned to Arm(s): 0.3 mg/kg or placebo sc (multiple dose)
D: Arm Label: 1: budesonide-MMX® 6 mg; Type: EXPERIMENTAL; Interventions: Procedure: Blood sampling, endoscopy, Drug: budesonide-MMX® 6 mg | Arm Label: 2: budesonide-MMX® 9 mg; Type: EXPERIMENTAL; Interventions: Procedure: Blood sampling, endoscopy, Drug: budesonide-MMX® 9 mg | Arm Label: 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Placebo | Arm Label: 4: Asacol® 400 mg; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Asacol® 400 mg | Intervention Type: PROCEDURE; Name: Blood sampling, endoscopy; Assigned to Arm(s): 1: budesonide-MMX® 6 mg, 2: budesonide-MMX® 9 mg, 3: Placebo, 4: Asacol® 400 mg | Intervention Type: DRUG; Name: budesonide-MMX® 6 mg; Assigned to Arm(s): 1: budesonide-MMX® 6 mg | Intervention Type: DRUG; Name: budesonide-MMX® 9 mg; Assigned to Arm(s): 2: budesonide-MMX® 9 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3: Placebo | Intervention Type: DRUG; Name: Asacol® 400 mg; Assigned to Arm(s): 4: Asacol® 400 mg

Answer: B