A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) (ATAMS)
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| ClinicalTrials.gov Identifier: NCT00642902 |
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Recruitment Status :
Terminated
(Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.)
First Posted : March 25, 2008
Results First Posted : May 24, 2016
Last Update Posted : May 24, 2016
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Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
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Brief Summary:
To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing Multiple Sclerosis | Drug: Atacicept Drug: Placebo matched to atacicept | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 255 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course |
| Study Start Date : | April 2008 |
| Actual Primary Completion Date : | September 2009 |
| Actual Study Completion Date : | September 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Arm | Intervention/treatment |
|---|---|
| Experimental: Atacicept 25 mg |
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks. |
| Experimental: Atacicept 75 mg |
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks. |
| Experimental: Atacicept 150 mg |
Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks. |
| Placebo Comparator: Placebo |
Drug: Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks. |
Primary Outcome Measures :
- Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan [ Time Frame: Weeks 12 to 36 ]Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).
Secondary Outcome Measures :
- Number of New T1 Gd-enhancing Lesions Per Participant [ Time Frame: Weeks 12, 24, 36 ]Analysis of new T1 Gd-enhancing lesions was done using MRI scans.
- Percentage of Participants Free From Relapses [ Time Frame: Baseline up to Week 36 ]A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature [axillary, orally, or intrauriculary] greater than (>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: From the first dose of study drug administration up to 12 weeks after the last dose of the study drug ]An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.
Exclusion Criteria:
- Have primary progressive multiple sclerosis (MS)
- Have secondary progressive MS without superimposed relapses
- Relevant cardiac, hepatic and renal diseases as specified in the protocol
- Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
- Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
- Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642902
Locations
Show 51 study locations
Sponsors and Collaborators
EMD Serono
Investigators
| Study Director: | Medical Responsible | EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00642902 |
| Other Study ID Numbers: |
28063 |
| First Posted: | March 25, 2008 Key Record Dates |
| Results First Posted: | May 24, 2016 |
| Last Update Posted: | May 24, 2016 |
| Last Verified: | April 2016 |
Keywords provided by EMD Serono:
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Relapsing Multiple Sclerosis Atacicept |
Additional relevant MeSH terms:
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |