Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Brief Summary: Primary Objectives:

Part A (dose ranging study):

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

* reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
* inhibition of progression of structural damage at 52 weeks
* improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.


Options:
A: Arm Label: Group 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Biological: Golimumab 50 mg | Arm Label: Group 2: Golimumab 50 mg; Type: EXPERIMENTAL; Interventions: Biological: Golimumab 50 mg | Arm Label: Group 3: Golimumab 100 mg; Type: EXPERIMENTAL; Interventions: Biological: Golimumab 100 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Group 1: Placebo | Intervention Type: BIOLOGICAL; Name: Golimumab 50 mg; Assigned to Arm(s): Group 1: Placebo, Group 2: Golimumab 50 mg | Intervention Type: BIOLOGICAL; Name: Golimumab 100 mg; Assigned to Arm(s): Group 3: Golimumab 100 mg
B: Arm Label: CDP870 100mg; Type: EXPERIMENTAL; Interventions: Drug: CDP870 100mg | Arm Label: CDP870 200mg; Type: EXPERIMENTAL; Interventions: Drug: CDP870 200mg | Arm Label: CDP870 400mg; Type: EXPERIMENTAL; Interventions: Drug: CDP870 400mg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo of CDP870 | Intervention Type: DRUG; Name: CDP870 400mg; Assigned to Arm(s): CDP870 400mg | Intervention Type: DRUG; Name: CDP870 200mg; Assigned to Arm(s): CDP870 200mg | Intervention Type: DRUG; Name: CDP870 100mg; Assigned to Arm(s): CDP870 100mg | Intervention Type: DRUG; Name: Placebo of CDP870; Assigned to Arm(s): Placebo
C: Arm Label: Part A: SAR 100 mg qw; Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part A: SAR 150 mg qw; Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part A: SAR 100 mg q2w; Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo (for sarilumab), Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part A: SAR 150 mg q2w; Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo (for sarilumab), Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part A: SAR 200 mg q2w; Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo (for sarilumab), Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part A: Placebo qw; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (for sarilumab), Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part B Cohort 1: Non-selected Doses; Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Placebo (for sarilumab), Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2); Type: EXPERIMENTAL; Interventions: Drug: Sarilumab, Drug: Methotrexate, Drug: Folic Acid | Arm Label: Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2); Type: EXPERIMENTAL; Interventions: Drug: Placebo (for sarilumab), Drug: Methotrexate, Drug: Folic Acid | Intervention Type: DRUG; Name: Sarilumab; Assigned to Arm(s): Part A: SAR 100 mg q2w, Part A: SAR 100 mg qw, Part A: SAR 150 mg q2w, Part A: SAR 150 mg qw, Part A: SAR 200 mg q2w, Part B Cohort 1: Non-selected Doses, Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2), Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2) | Intervention Type: DRUG; Name: Placebo (for sarilumab); Assigned to Arm(s): Part A: Placebo qw, Part A: SAR 100 mg q2w, Part A: SAR 150 mg q2w, Part A: SAR 200 mg q2w, Part B Cohort 1: Non-selected Doses, Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2) | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): Part A: Placebo qw, Part A: SAR 100 mg q2w, Part A: SAR 100 mg qw, Part A: SAR 150 mg q2w, Part A: SAR 150 mg qw, Part A: SAR 200 mg q2w, Part B Cohort 1: Non-selected Doses, Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2), Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2), Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2) | Intervention Type: DRUG; Name: Folic Acid; Assigned to Arm(s): Part A: Placebo qw, Part A: SAR 100 mg q2w, Part A: SAR 100 mg qw, Part A: SAR 150 mg q2w, Part A: SAR 150 mg qw, Part A: SAR 200 mg q2w, Part B Cohort 1: Non-selected Doses, Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2), Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2), Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
D: Arm Label: 1a; Type: ACTIVE_COMPARATOR; Interventions: Drug: Etanercept, Drug: Methotrexate | Arm Label: 1b; Type: ACTIVE_COMPARATOR; Interventions: Drug: Etanercept, Drug: Methotrexate, Drug: Placebo | Arm Label: 2a; Type: ACTIVE_COMPARATOR; Interventions: Drug: Etanercept, Drug: Methotrexate, Drug: Placebo | Arm Label: 2b; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methotrexate | Intervention Type: DRUG; Name: Etanercept; Assigned to Arm(s): 1a, 1b, 2a | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): 1a, 1b, 2a, 2b | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 1b, 2a

Answer: C