Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy
Brief Summary: Phase IV

Design : Prospective, open-label, randomized three-arms study

Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months

Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration

Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.

Number of subjects 225 randomized patients (75 per arm)

Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Measurement of serum infliximab and anti-infliximab antibodies | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status | Intervention Type: PROCEDURE; Name: Measurement of serum infliximab and anti-infliximab antibodies; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status; Assigned to Arm(s): 2
B: Arm Label: INFLIXIMAB AND ANTI METABOLITE; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: STOP INFLIXIMAB CONTINUING ANTI METABOLITE; Type: OTHER; Interventions: Drug: INFLIXIMAB | Arm Label: CONTINUING INFLIXIMAB AND discontinuing anti-metabolites; Type: OTHER; Interventions: Drug: AZATHIOPRINE, Drug: MERCAPTOPURINE, Drug: Methotrexate | Intervention Type: DRUG; Name: INFLIXIMAB; Assigned to Arm(s): STOP INFLIXIMAB CONTINUING ANTI METABOLITE | Intervention Type: DRUG; Name: AZATHIOPRINE; Assigned to Arm(s): CONTINUING INFLIXIMAB AND discontinuing anti-metabolites | Intervention Type: DRUG; Name: MERCAPTOPURINE; Assigned to Arm(s): CONTINUING INFLIXIMAB AND discontinuing anti-metabolites | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): CONTINUING INFLIXIMAB AND discontinuing anti-metabolites
C: 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
D: Arm Label: Infliximab; Type: EXPERIMENTAL; Interventions: Biological: Infliximab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: BIOLOGICAL; Name: Infliximab; Assigned to Arm(s): Infliximab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B