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: Arm Label: control = conventional treatment; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Immunossuppresive treatment; Type: EXPERIMENTAL; Interventions: Drug: early immunosuppressants (azathioprine, methotrexate) | Intervention Type: DRUG; Name: early immunosuppressants (azathioprine, methotrexate); Assigned to Arm(s): Immunossuppresive treatment
B: 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
C: Arm Label: Azathioprine; Type: EXPERIMENTAL; Interventions: Drug: Azathioprine, Drug: Mesalazine placebo | Arm Label: Mesalazine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mesalazine, Drug: Azathioprine placebo | Intervention Type: DRUG; Name: Azathioprine; Assigned to Arm(s): Azathioprine | Intervention Type: DRUG; Name: Mesalazine; Assigned to Arm(s): Mesalazine | Intervention Type: DRUG; Name: Azathioprine placebo; Assigned to Arm(s): Mesalazine | Intervention Type: DRUG; Name: Mesalazine placebo; Assigned to Arm(s): Azathioprine
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: infliximab+azathioprine | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: methylprednisolone or budesonide | Intervention Type: DRUG; Name: infliximab+azathioprine; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: methylprednisolone or budesonide; Assigned to Arm(s): 2

Answer: B