BEYOND Pilot Study

Bayer

Status and phase

Completed

Phase 2

Conditions

Relapsing-Remitting

Multiple Sclerosis

Treatments

Drug: Betaseron (Interferon beta-1b, BAY86-5046)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00893217

91232

307000

BEYOND pilot

Details and patient eligibility

About

The purpose of this study is to valuate safety and tolerability of Betaseron.

Enrollment

71 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of RRMS as defined by any of the following McDonald diagnostic criteria (McDonald et al 2001; see Appendix 16.1.1 [(Protocol Appendix 5]):

Two relapses and objective clinical evidence (history or present) of at least 2 lesions
Two relapses and objective clinical evidence (history or present) of 1 lesion; and dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria) or 2 MRI T2 lesions consistent with MS plus positive CSF.
One relapse with objective clinical evidence (history or present) of at least 2 lesions, and dissemination in time, demonstrated signs of disease activity ( new Gd+ lesion or new T2 lesion) in an MRI scan at least 3 months after the onset of that clinical event.
One relapse and objective clinical evidence (history or present) of 1 lesion, and dissemination in space, demonstrated by MRI (Barkhof/Tintoré criteria); or 2 MRI T2 lesions consistent with MS plus positive CSF, and dissemination in time, demonstrated by signs of disease activity (new Gd+ lesion or new T2 lesion) in an MRI scan at least 3 months after the onset of that clinical event.
- 18 to 55 years of age
- Score of 0-5.5 on the Kurtzke Expanded Disability Status Scale' (EDSS; see Appendix 16.1.1 [Protocol Appendix 4])
- Naïve to immunomodulating therapies or previously treated with immunomodulating therapies other than any interferon (IFN) more than 30 days prior to the start of the study
- If female of child-bearing potential, agreement to practice adequate contraception methods (IUCD, condoms, oral contraceptives, or other adequate barrier contraception)
- Negative serum pregnancy test results.
- Signed and dated statement of informed consent

Exclusion criteria

Clinically significant heart disease such as uncontrolled cardiac dysrhythmia, angina pectoris, cardiomyopathy, or congestive heart failure
History of severe depression, suicide attempts, or current suicidal ideations
Clinically significant liver, renal, and bone marrow dysfunction as defined by any of the following laboratory evaluations:
bone marrow dysfunction:
- Hb <8.5 g/dl
- WBC <2.5 x 109/L
- platelet count <125 x 109/L
renal dysfunction: creatinine >1.8 mg/dL
liver dysfunction:
- ASAT (SGOT) >3xupper limit of normal
- bilirubin >2x upper limit of normal
Epilepsy not adequately controlled by treatment
Any conditions that could interfere with the MRI or any other evaluation in the study
Known allergy to human proteins including albumin and IFN, or to mannitol or gadolinium
Participation in any clinical study within the past 30 days or use/intake of an investigational drug within the last 3 months prior to study entry
Prior treatment with monoclonal antibody therapy, cladribine or total lymphoid irradiation
Treatment with cytotoxic or immunosuppressive therapies (except systemic steroid or adrenocorticotropic hormone [ACTH]) within 6 months prior to study entry; or systemic steroid or ACTH within 1 month prior to study entry
Presence of monoclonal gammopathy
Inability to tolerate both NSAIDs and acetaminophen
Pregnancy or lactation
History of alcohol or drug abuse
Inability to administer subcutaneous injections either by self or by caregiver
Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study