Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
Brief Summary: The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.


Options:
A: Arm Label: Vedolizumab; Type: EXPERIMENTAL; Interventions: Drug: vedolizumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: vedolizumab; Assigned to Arm(s): Vedolizumab | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: 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
C: 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: Entocort EC® 3 mg; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Entocort EC® 3 mg | Arm Label: 4: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Placebo | Intervention Type: PROCEDURE; Name: Blood sampling, endoscopy; Assigned to Arm(s): 1: budesonide-MMX® 6 mg, 2: budesonide-MMX® 9 mg, 3: Entocort EC® 3 mg, 4: Placebo | 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: Entocort EC® 3 mg; Assigned to Arm(s): 3: Entocort EC® 3 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4: Placebo
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: budesonide | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: mesalazine | Intervention Type: DRUG; Name: budesonide; Assigned to Arm(s): A | Intervention Type: DRUG; Name: mesalazine; Assigned to Arm(s): B

Answer: B