Relapsing Multiple SclerosisPhase 2ATAMSNCT00642902
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
A Phase 2 study testing Atacicept in people with Relapsing Multiple Sclerosis, run by EMD Serono at 50 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Atacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 50 sitesin 17 countries
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.
Who cannot join
- 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.
Trial locations and contacts
50 sites in 17 countries.
50 sites in 17 countries
United States8 sites
Research Site
Atlanta, Georgia
Research Site
Cleveland, Ohio
Research Site
East Lansing, Michigan
Research Site
Jefferson, New Hampshire
Research Site
Nashville, Tennessee
Research Site
Northbrook, Illinois
Study site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Russia8 sites
Research Site
Dnipropetrovsk
Research Site
Moscow
Research Site
Novosibirsk
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Vladimir
Research Site
Yaroslavl
Research Site
Yekaterinburg
Australia4 sites
Research Site
Box Hill
Research Site
Fitzroy
Research Site
New Lambton
Research Site
Woodville
Ukraine4 sites
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Odesa
Research Site
Uzhhorod
Canada3 sites
Research Site
Calgary, Alberta
Research Site
Ontario
Research Site
Ottawa, Ontario
Czechia3 sites
Research Site
Brno
Research Site
Hradec Králové
Research Site
Olomouc
Netherlands3 sites
Research Site
Breda
Research Site
Nieuwegein
Research Site
Rotterdam
United Kingdom3 sites
Research Site
London
Research Site
Sheffield
Research Site
Stoke-on-Trent
About this study
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
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.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Atacicept, Placebo matched to atacicept
- Keywords
- Relapsing Multiple Sclerosis, Atacicept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaciceptDrug
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.
AtaciceptDrug
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.
AtaciceptDrug
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 matched to ataciceptDrug
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Atacicept 25 mg | Experimental | Not described Receives: Drug: Atacicept |
| Atacicept 75 mg | Experimental | Not described Receives: Drug: Atacicept |
| Atacicept 150 mg | Experimental | Not described Receives: Drug: Atacicept |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matched to atacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
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).
Measured: Weeks 12 to 36
Secondary outcomes (3)
Number of New T1 Gd-enhancing Lesions Per Participant
Analysis of new T1 Gd-enhancing lesions was done using MRI scans.
Measured: Weeks 12, 24, 36
Percentage of Participants Free From Relapses
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.
Measured: Baseline up to Week 36
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
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.
Measured: From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642902
- Sponsor's protocol ID
- 28063
- Acronym
- ATAMS
- Status last verified
- Apr 2016
- First submitted
- 21 Mar 2008
- Last updated
- 24 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kappos L, Hartung HP, Freedman MS, Boyko A, Radu EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.
PubMed 24613349
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00642902
- Acronym / sponsor ID
- ATAMS / 28063
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Relapsing Multiple Sclerosis, Atacicept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.
- Enrolment
- 255 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 24 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atacicept 25 mg | Experimental | Drug: Atacicept |
| Atacicept 75 mg | Experimental | Drug: Atacicept |
| Atacicept 150 mg | Experimental | Drug: Atacicept |
| Placebo | Placebo comparator | Drug: Placebo matched to atacicept |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtaciceptAtacicept 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. | Drug | Atacicept 25 mg |
| AtaciceptAtacicept 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. | Drug | Atacicept 75 mg |
| AtaciceptAtacicept 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. | Drug | Atacicept 150 mg |
| Placebo matched to ataciceptPlacebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks. | Drug | Placebo |
Primary outcome
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).
3 secondary outcomes
Number of New T1 Gd-enhancing Lesions Per Participant
Time frame: Weeks 12, 24, 36
Percentage of Participants Free From Relapses
Time frame: Baseline up to Week 36
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24613349Kappos L, Hartung HP, Freedman MS, Boyko A, Radu EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
50 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atacicept in people with Relapsing Multiple Sclerosis, run by EMD Serono at 50 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Russia, Australia, Ukraine, Canada and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (time frame: Weeks 12 to 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.