Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.
Brief Summary: This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.


Options:
A: Arm Label: Immediate Treatment Group; Type: EXPERIMENTAL; Interventions: Drug: interferon beta 1a 30 ug IM once weekly | Arm Label: Delayed Treatment Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: interferon beta 1a 30 ug IM once weekly | Intervention Type: DRUG; Name: interferon beta 1a 30 ug IM once weekly; Assigned to Arm(s): Delayed Treatment Group, Immediate Treatment Group
B: Arm Label: Several diagnostic procedures; Type: OTHER; Interventions: Procedure: Several diagnostic procedures | Intervention Type: PROCEDURE; Name: Several diagnostic procedures; Assigned to Arm(s): Several diagnostic procedures
C: Arm Label: Cladribine 5.25 mg/kg (ITP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg (ITP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo (ITP); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 5.25 mg/kg, Rebif (OLMP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg, Rebif (OLMP); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo, Rebif (OLMP); Type: EXPERIMENTAL; Interventions: Drug: Placebo | Arm Label: Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Placebo | Arm Label: Cladribine 5.25 mg/kg, Rebif (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Cladribine 3.5 mg/kg, Rebif (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Cladribine, Drug: Rebif® new formulation (RNF) | Arm Label: Placebo, Rebif (LTFU); Type: EXPERIMENTAL; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Cladribine; Assigned to Arm(s): Cladribine 3.5 mg/kg (ITP), Cladribine 3.5 mg/kg, Rebif (LTFU), Cladribine 3.5 mg/kg, Rebif (OLMP), Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU), Cladribine 5.25 mg/kg (ITP), Cladribine 5.25 mg/kg, Rebif (LTFU), Cladribine 5.25 mg/kg, Rebif (OLMP), Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (ITP), Placebo, Rebif (LTFU), Placebo, Rebif (OLMP), Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU) | Intervention Type: DRUG; Name: Rebif® new formulation (RNF); Assigned to Arm(s): Cladribine 3.5 mg/kg (ITP), Cladribine 3.5 mg/kg, Rebif (LTFU), Cladribine 3.5 mg/kg, Rebif (OLMP), Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU), Cladribine 5.25 mg/kg (ITP), Cladribine 5.25 mg/kg, Rebif (LTFU), Cladribine 5.25 mg/kg, Rebif (OLMP), Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU), Placebo (ITP)
D: Arm Label: Initial IFNB-1b (Interferon beta-1b); Type: EXPERIMENTAL; Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Arm Label: Initial Placebo; Type: EXPERIMENTAL; Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Intervention Type: DRUG; Name: Interferon beta-1b (Betaseron, BAY86-5046); Assigned to Arm(s): Initial IFNB-1b (Interferon beta-1b) | Intervention Type: DRUG; Name: Interferon beta-1b (Betaseron, BAY86-5046); Assigned to Arm(s): Initial Placebo

Answer: D