BEYOND Pilot Study

Phase 2

Completed

• Conditions: Multiple Sclerosis; Relapsing-Remitting
• Interventions: Drug: Betaseron (Interferon beta-1b, BAY86-5046)

• Registration Number: NCT00893217
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-06
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-06
• Last Update Posted: 2009-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Betaseron (Interferon beta-1b, BAY86-5046)	-
Arm 2	Betaseron (Interferon beta-1b, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of IFNB-1b 500 mcg given subcutaneously (SC) QOD compared with the standard dose of 250 mcg QOD in patients with RRMS.	8 Months