Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.


Options:
A: Intervention Type: DRUG; Name: Certolizumab Pegol (CDP870); Assigned to Arm(s): N/A
B: Arm Label: Population 1: Placebo SC followed by ustekinumab SC; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 90 mg, Drug: Placebo SC | Arm Label: Population 1: Ustekinumab SC followed by Placebo SC:; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 90 mg, Drug: Placebo SC | Arm Label: Population 1: Placebo IV followed by ustekinumab IV; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 4.5 mg/kg, Drug: Placebo IV | Arm Label: Population 1: Ustekinumab IV followed by Placebo IV:; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 4.5 mg/kg, Drug: Placebo IV | Arm Label: Population 2: Ustekinumab SC; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 90 mg | Arm Label: Population 2: Ustekinumab IV; Type: EXPERIMENTAL; Interventions: Drug: Ustekinumab 4.5 mg/kg | Intervention Type: DRUG; Name: Ustekinumab 90 mg; Assigned to Arm(s): Population 1: Placebo SC followed by ustekinumab SC, Population 1: Ustekinumab SC followed by Placebo SC:, Population 2: Ustekinumab SC | Intervention Type: DRUG; Name: Ustekinumab 4.5 mg/kg; Assigned to Arm(s): Population 1: Placebo IV followed by ustekinumab IV, Population 1: Ustekinumab IV followed by Placebo IV:, Population 2: Ustekinumab IV | Intervention Type: DRUG; Name: Placebo SC; Assigned to Arm(s): Population 1: Placebo SC followed by ustekinumab SC, Population 1: Ustekinumab SC followed by Placebo SC: | Intervention Type: DRUG; Name: Placebo IV; Assigned to Arm(s): Population 1: Placebo IV followed by ustekinumab IV, Population 1: Ustekinumab IV followed by Placebo IV:
C: Arm Label: CNTO1275 (ustekinumab); Type: EXPERIMENTAL; Interventions: Drug: CNTO 1275 63 mg, Drug: Placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: CNTO 1275 63 mg, Drug: Placebo | Intervention Type: DRUG; Name: CNTO 1275 63 mg; Assigned to Arm(s): CNTO1275 (ustekinumab), Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): CNTO1275 (ustekinumab), Placebo
D: Arm Label: 003; Type: EXPERIMENTAL; Interventions: Other: infliximab (IFX) infusion; azathioprine (AZA) caps | Arm Label: 001; Type: EXPERIMENTAL; Interventions: Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps | Arm Label: 002; Type: EXPERIMENTAL; Interventions: Biological: infliximab infusion; AZA placebo caps | Intervention Type: BIOLOGICAL; Name: infliximab infusion; AZA placebo caps; Assigned to Arm(s): 002 | Intervention Type: OTHER; Name: infliximab (IFX) infusion; azathioprine (AZA) caps; Assigned to Arm(s): 003 | Intervention Type: DRUG; Name: infliximab (IFX) placebo infusion; azathioprine (AZA) caps; Assigned to Arm(s): 001

Answer: D