Trial · NCT00642902
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
NCT00642902, Phase 2, Terminated, EMD Serono; results first posted 2016-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS). Trials, record NCT00642902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00642902
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
- NCT number
- NCT00642902
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 255 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Atacicept, Atacicept, Atacicept, Placebo matched to atacicept
- First posted
- 2008-03-25
- Last updated
- 2016-05-24
- Results first posted
- 2016-05-24
- Limitations and caveats
Sponsor voluntarily decided to prematurely terminate this trial due to an increase in multiple sclerosis (MS) disease activity observed in atacicept arms as compared to placebo during a routine independent data monitoring committee (IDMC) review.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan | 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 | Number of New T1 Gd-enhancing Lesions Per Participant | Weeks 12, 24, 36 | Analysis of new T1 Gd-enhancing lesions was done using MRI scans. |
| Secondary | Percentage of Participants Free From Relapses | 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. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan | Weeks 12 to 36 | ITT population included all randomized participants. | lesions/participant/scan | MEAN |
| SECONDARY | Number of New T1 Gd-enhancing Lesions Per Participant | Weeks 12, 24, 36 | ITT population included all randomized participants. 'n' signifies participants who were evaluable for this measure at given time points for each group, respectively. | lesions/participant | MEAN |
| SECONDARY | Percentage of Participants Free From Relapses | Baseline up to Week 36 | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | From the first dose of study drug administration up to 12 weeks after the last dose of the study drug | Safety population included all participants who received at least 1 dose of treatment (either active or placebo). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan | Placebo | 3.07 | 95% Confidence Interval 1.40 to 6.77 | lesions/participant/scan | |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan | Atacicept 25 mg | 2.26 | 95% Confidence Interval 0.97 to 5.27 | lesions/participant/scan | |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan | Atacicept 75 mg | 2.30 | 95% Confidence Interval 1.08 to 4.92 | lesions/participant/scan | |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan | Atacicept 150 mg | 2.49 | 95% Confidence Interval 1.18 to 5.27 | lesions/participant/scan | |
| Number of New T1 Gd-enhancing Lesions Per Participant | Placebo | Week 12 (n=55, 45, 50, 55) | 2.55 | Standard Deviation 7.95 | lesions/participant |
| Number of New T1 Gd-enhancing Lesions Per Participant | Atacicept 25 mg | Week 12 (n=55, 45, 50, 55) | 2.71 | Standard Deviation 7.67 | lesions/participant |
| Number of New T1 Gd-enhancing Lesions Per Participant | Atacicept 75 mg | Week 12 (n=55, 45, 50, 55) | 3.20 | Standard Deviation 6.41 | lesions/participant |
| Number of New T1 Gd-enhancing Lesions Per Participant | Atacicept 150 mg | Week 12 (n=55, 45, 50, 55) | 2.96 | Standard Deviation 6.58 | lesions/participant |
| Number of New T1 Gd-enhancing Lesions Per Participant | Placebo | Week 24 (n=41, 34, 37, 41) | 0.83 | Standard Deviation 1.70 | lesions/participant |
| Number of New T1 Gd-enhancing Lesions Per Participant | Atacicept 25 mg | Week 24 (n=41, 34, 37, 41) | 1.50 | Standard Deviation 2.79 | lesions/participant |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 63 | |
| Overall Study | STARTED | Atacicept 25 mg | 63 | |
| Overall Study | STARTED | Atacicept 75 mg | 64 | |
| Overall Study | STARTED | Atacicept 150 mg | 65 | |
| Overall Study | Treated | Placebo | 63 | |
| Overall Study | Treated | Atacicept 25 mg | 63 | |
| Overall Study | Treated | Atacicept 75 mg | 63 | |
| Overall Study | Treated | Atacicept 150 mg | 65 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | COMPLETED | Atacicept 25 mg | 21 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | General disorders | Placebo | 8 | 63 | |
| other | Injection site reaction | General disorders | Atacicept 25 mg | 19 | 63 | |
| other | Injection site reaction | General disorders | Atacicept 75 mg | 24 | 63 | |
| other | Injection site reaction | General disorders | Atacicept 150 mg | 32 | 65 | |
| other | Fatigue | General disorders | Placebo | 0 | 63 | |
| other | Fatigue | General disorders | Atacicept 25 mg | 1 | 63 | |
| other | Fatigue | General disorders | Atacicept 75 mg | 3 | 63 | |
| other | Fatigue | General disorders | Atacicept 150 mg | 4 | 65 | |
| other | Injection site pain | General disorders | Placebo | 2 | 63 | |
| other | Injection site pain | General disorders | Atacicept 25 mg | 2 | 63 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Atacicept 25 mg | ||
| Total, all-cause mortality | Atacicept 75 mg | ||
| Total, all-cause mortality | Atacicept 150 mg | ||
| Total, other adverse events | Placebo | 33 | 63 |
| Total, other adverse events | Atacicept 25 mg | 30 | 63 |
| Total, other adverse events | Atacicept 75 mg | 34 | 63 |
| Total, other adverse events | Atacicept 150 mg | 44 | 65 |
| Total, serious adverse events | Placebo | 1 | 63 |
| Total, serious adverse events | Atacicept 25 mg | 3 | 63 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24613349 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00642902
GET https://conductscience.org/api/trials/v1/NCT00642902/results?page=2