Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) (REFLEXION)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Drug: RNF; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813709

28981

Details and patient eligibility

About

REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).

Full description

The objective of the study is to investigate whether RNF treatment initiated after the first clinical event versus delayed treatment results in the prolongation of time to Clinically Definite Multiple Sclerosis (CDMS) conversion up to Month 36 and up to Month 60 since randomization in Study 27025 (REFLEX). Furthermore, the study is intended to explore whether RNF treatment initiated after the first clinical event versus delayed treatment delays disability (including development of secondary progressive MS) and reduces disease activity (including the annual relapse rate [ARR]) in the long term (up to Month 36 and up to Month 60 since randomization in Study 27025 (REFLEX). The study will also assess the long-term safety profile of RNF (up to Month 36 and up to Month 60 since randomization in Study 27025 (REFLEX).

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reach scheduled end of study in Study 27025 (REFLEX) (completion of 24 months participation)

• Medical assessment by the Investigator/treating physician from study 27025 that there is no objection to the subject's participation in this extension trial considering the medical experience from Study 27025 (REFLEX). Special attention should be given to laboratory abnormalities and clinically significant liver, renal and bone-marrow dysfunction

• If female, subject must:

  • be neither pregnant nor breast-feeding, nor attempting to conceive
  • use a highly effective method of contraception. A highly effective method of contraception is defined as those which result in a low failure rate (that is [i.e.] less than 1 percent [%] per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner

• Subject is willing to follow study procedures

• Subject has given written informed consent

Exclusion criteria

• Subject has any disease other than MS that could better explain the subject's signs and symptoms
• Subject has a primary progressive course of MS
• Subject has total bilirubin greater than 2.5 times upper limit of normal (ULN) at both Month 24 and at the previous visit (i.e. Month 21) (subjects with greater than 2.5 times ULN at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalization of the value)
• Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase (ALP) greater than 2.5 times the ULN values at both Month 24 and at the previous visit (i.e. Month 21) (subjects with greater than 2.5 times ULN at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalization of the value)
• Subject suffers from another current autoimmune disease
• Subject suffers from major medical or psychiatric illness (including history of, or current, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
• Subject has a history of seizures not adequately controlled by treatment
• Subject has cardiac disease, such as angina, congestive heart failure or arrhythmia
• Subject has a known allergy to IFN-beta or the excipient(s) of the study medication
• Subject has any condition that could interfere with the MRI evaluation
• Subject has a known allergy to gadolinium-diethylene triamine pentaacetic acid (DTPA)
• Subject has a history of alcohol or drug abuse
• Subject has previously participated in this study
• Subject has moderate to severe renal impairment
• Subject is pregnant or lactating
• Subject has any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol, or to complete the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

402 participants in 3 patient groups

RNF 44 mcg thrice weekly

Active Comparator group

Treatment:

Drug: RNF

Drug: RNF

Drug: RNF

RNF 44 mcg once weekly and placebo

Active Comparator group

Treatment:

Drug: Placebo

Drug: RNF

Drug: RNF

Drug: RNF

Placebo/RNF 44 mcg thrice weekly

Active Comparator group

Treatment:

Drug: RNF

Drug: RNF

Drug: RNF