Ignite Creation Date:
2024-05-05 @ 10:34 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01134627
Status:
TERMINATED
Last Update Posted:
2013-12-27
First Post:
2010-05-28
Brief Title:
Minocycline as add-on to Interferon Beta-1a IFN Beta-1a Rebif in Relapsing-Remitting Multiple Sclerosis RRMS
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Multi-centre Double Blind Randomized Placebo Controlled Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw Rebif for the Treatment of Relapsing-Remitting Multiple Sclerosis
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECYCLINE
Brief Summary:
This is a multicentric double-blind placebo-controlled randomized parallel group study to estimate the effect of minocycline as add-on to interferon beta-1a IFN beta-1a in subjects with relapsing-remitting multiple sclerosis RRMS
Detailed Description:
Interferon beta-1a is the approved standard therapy in RRMS The beneficial effects of minocycline in the experimental autoimmune encephalomyelitis EAE model and its possible inhibitory effect on the degradation of IFN beta-1a suggest that minocycline treatment may have beneficial effects in MS as add-on therapy in subjects who are on treatment with IFN beta-1a Adjuvant treatment with minocycline is easy to administer well tolerated and relatively inexpensive This is a multicentric double blind placebo controlled randomized parallel group study Eligible subjects already started with IFN beta-1a Rebif will be randomized 11 for treatment with either minocycline 2100 mg daily as add-on therapy or placebo The subjects will be examined clinically at baseline and after 12 24 48 72 and 96 weeks Laboratory tests hematology and clinical chemistry will be performed at baseline and after 4 8 12 24 36 48 60 72 84 and 96 weeks at 4 8 36 60 and 84 weeks only an additional liver enzyme test will be scheduled The MRI T1-weighted and T2-weighted before treatment and after 96 weeks and immunological studies before treatment and after 48 weeks will be performed in a limited number of subjects in selected centers
OBJECTIVES
Primary Objective
The effect of minocycline versus placebo in subjects receiving treatment with IFN beta-1a on the time to the first documented relapse
Secondary Objectives
To estimate the effect of minocycline versus placebo in subjects receiving treatment with IFN beta-1a on the mean number of documented relapses per subject up to year 2
To estimate in a limited number of 120 subjects at pre-selected sites the effect of minocycline versus placebo in subjects receiving treatment with IFN beta-1a on the number of new or enlarging lesions on T2-weighted MRI changes in brain volume measured on MRI
Tertiary Objectives
Time to onset of disability progression sustained over at least 6 months based on change from baseline in EDSS in subjects with RRMS who recently started treatment with IFN beta-1a Disability progression is defined as an increase of 10 point on the EDSS if EDSS was 10 at baseline and 15 point on the EDSS if EDSS was 00 at baseline
Time to sustained progression by 2 points in 1 Functional System or 1 point in 2 Functional Systems
The total number of reported relapses documented and undocumented An undocumented relapse is defined as the appearance of new symptoms or worsening of an old symptom in the absence of fever over at least 24 hours that could be attributed to MS activity preceded by stability or improvement for at least 30 days
The requirement for treatment with glucocorticoids due to relapses
The time to first relapse
The number of relapse-free documented and undocumented relapses subjects without progression
The disease activity measured on the integrated disability status scale IDSS
The number of subjects with a permanent loss of disability of 10 score on the EDSS confirmed at 2 consecutive visits with an interval of 6 months
The total area of MS lesions on T1 and T2-weighted MRI
Analyze the safety with respect to the combination of Rebif and minocycline
Rate of dose reduction of IFN beta-1a Rebif
Relapse severity based on the EDSS and IDSS
Immunological analyses in a limited number of subjects MRI subgroup
Frequency of increase of liver enzymes according to World Health Organization WHO II criteria
OBJECTIVES
Primary Objective
The effect of minocycline versus placebo in subjects receiving treatment with IFN beta-1a on the time to the first documented relapse
Secondary Objectives
To estimate the effect of minocycline versus placebo in subjects receiving treatment with IFN beta-1a on the mean number of documented relapses per subject up to year 2
To estimate in a limited number of 120 subjects at pre-selected sites the effect of minocycline versus placebo in subjects receiving treatment with IFN beta-1a on the number of new or enlarging lesions on T2-weighted MRI changes in brain volume measured on MRI
Tertiary Objectives
Time to onset of disability progression sustained over at least 6 months based on change from baseline in EDSS in subjects with RRMS who recently started treatment with IFN beta-1a Disability progression is defined as an increase of 10 point on the EDSS if EDSS was 10 at baseline and 15 point on the EDSS if EDSS was 00 at baseline
Time to sustained progression by 2 points in 1 Functional System or 1 point in 2 Functional Systems
The total number of reported relapses documented and undocumented An undocumented relapse is defined as the appearance of new symptoms or worsening of an old symptom in the absence of fever over at least 24 hours that could be attributed to MS activity preceded by stability or improvement for at least 30 days
The requirement for treatment with glucocorticoids due to relapses
The time to first relapse
The number of relapse-free documented and undocumented relapses subjects without progression
The disease activity measured on the integrated disability status scale IDSS
The number of subjects with a permanent loss of disability of 10 score on the EDSS confirmed at 2 consecutive visits with an interval of 6 months
The total area of MS lesions on T1 and T2-weighted MRI
Analyze the safety with respect to the combination of Rebif and minocycline
Rate of dose reduction of IFN beta-1a Rebif
Relapse severity based on the EDSS and IDSS
Immunological analyses in a limited number of subjects MRI subgroup
Frequency of increase of liver enzymes according to World Health Organization WHO II criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-004289-18 | EUDRACT_NUMBER | None | None |