BEYOND Pilot Study

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Interferon beta-1b; Interferon-beta; Interferons

Criteria

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