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NCT00853762 · ClinicalTrials.gov registry record · Phase 2

Atacicept in Multiple Sclerosis Extension Study, Phase II

A Phase 2 study, sponsored by EMD Serono.

Terminated
Registry status
Phase 2
Development phase
74
Enrollment target

NCT00853762 is a Phase 2 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 74 participants.

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The verdict

NCT00853762, a Phase 2 study, was terminated before completion, sponsored by EMD Serono.

TERMINATED
Registry status
Phase 2
Development phase
74 participants
Enrollment target

Study Summary

This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS). This extension study consists of two parts. Part A will be double blind and Part B will be open label. During Part A, subjects initially randomized to atacicept will continue to receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are available and the atacicept dose with the best benefit / risk ratio has been identified, all subjects will be switched to this dose and will continue the extension study open-label (Part B). Throughout the study, subjects and investigators will remain blinded with respect to initial and part A treatment allocation/dose.

Interventions

  • DRUG Atacicept 75 mg
  • DRUG Atacicept 150 mg
  • DRUG Atacicept 25 mg

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2009-03
Est. Completion 2011-02
Phase Phase 2

Sponsor

EMD Serono

71 total trials

What the Registry Record Tells You About NCT00853762

The ClinicalTrials.gov registry entry for NCT00853762 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Atacicept 75 mg is the first listed.

NCT00853762 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00853762 about?

NCT00853762 is a clinical study titled "Atacicept in Multiple Sclerosis Extension Study, Phase II". This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS). This extension study consists o...

What is the current status of trial NCT00853762?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2009-03. Estimated completion is 2011-02.

What interventions are being tested in trial NCT00853762?

The interventions under investigation include: Atacicept 75 mg (DRUG), Atacicept 150 mg (DRUG), Atacicept 25 mg (DRUG).

Who is sponsoring clinical trial NCT00853762?

This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.