ATAMS
What it found
The trial ended early for another reason (see below).
| Group | n | Value |
|---|---|---|
| atacicept 25 mg | 63 | 2.26 (95% CI 0.97-5.27) |
| placebo | 63 | 3.07 (1.40-6.77) |
Total participants: 255
Read by software from the paper's abstract
Reason given: Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.
What was tested
Treatment tested
- Atacicept
Tumor necrosis factor ligand superfamily member 13 inhibitor|Tumor necrosis factor ligand superfamily member 13B inhibitor
Placebo or sham
- Placebo matched to atacicept
Results by group
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
Weeks 12 to 36
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 3.07 lesions/participant/scan | 1.4–6.77 | 63 |
| Atacicept 25 mg | 2.26 lesions/participant/scan | 0.97–5.27 | 63 |
| Atacicept 75 mg | 2.30 lesions/participant/scan | 1.08–4.92 | 64 |
| Atacicept 150 mg | 2.49 lesions/participant/scan | 1.18–5.27 | 65 |
Placebo
Atacicept 25 mg
Atacicept 75 mg
Atacicept 150 mg
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 63 | 1 (1.6%) | |
| Atacicept 25 mg | 63 | 3 (4.8%) | |
| Atacicept 75 mg | 63 | 3 (4.8%) | |
| Atacicept 150 mg | 65 | 1 (1.5%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
Weeks 12 to 36
MRI lesions
Other measures (3)
Number of New T1 Gd-enhancing Lesions Per Participant
Weeks 12, 24, 36
MRI lesionsPercentage of Participants Free From Relapses
Baseline up to Week 36
Disability progressionRelapsesNumber 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
Who could take part
Relapsing MS · 18 to 60
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial.Lancet Neurol · 2014
Mean numbers of gadolinium-enhancing T1 lesions per scan were similar in all groups (25 mg, 2·26, 0·97-5·27; 75 mg, 2·30, 1·08-4·92; 150 mg, 2·49, 1·18-5·27; placebo, 3·07, 1·40-6·77).
Read by software from the paper's abstract
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Linked trials
Extended by
ATAMS extPhase 2 · Stopped early
Links found where a registry record names another trial's registry number.
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History
Started
Apr 2008
Main results due
Sept 2009
Finished
Sept 2009
Results posted
May 2016
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