Trial · NCT00853762
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity | From the first dose of study drug administration up to Week 24 | Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. | Subjects | NUMBER |
| PRIMARY | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 | Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category. | millimeter of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Vital Signs: Pulse Rate | Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 | Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category. | beats per minute (beats/min) | MEAN |
| PRIMARY | Change From Baseline in Vital Signs: Temperature | Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 | Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category. | Degree Celsius | MEAN |
| PRIMARY | Change From Baseline in Electrocardiogram (ECGs) | Baseline, Week 12 and 36 | No summary tables were prepared for ECG parameters, and ECG data were not formally analyzed. However, a qualitative assessment of ECG morphology and rhythm was made by the Investigator and recorded in the electronic case report form (eCRF). ECG abnormalities considered significant by the investigator were reported as AEs. | ||
| PRIMARY | Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels | Baseline up to Week 36 | Intent-to-treat (ITT) population included all randomized subjects. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Clinical Attacks/Relapses | Baseline up to Week 24 | Intent-to-treat (ITT) population included all randomized subjects. | Subjects | NUMBER |
| SECONDARY | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT) population included all randomized subjects. N signifies (total number of subjects analyzed) the number of evaluable subjects for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12 | Week 12 | Intent-to-treat (ITT) population included all randomized subjects. N signifies number of evaluable subjects for this outcome measure. | z-score | MEAN |
| SECONDARY | Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject | Baseline, Week 12 and 24 | Intent-to-treat (ITT) population included all randomized subjects. n signifies the number of evaluable subjects for this outcome measure. | Number of lesions per subject | MEAN |
| SECONDARY | Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject | Baseline, Week 12 and Week 24 | Cubic millimeter | MEAN | |
| SECONDARY | Concentrations of Free and Total Atacicept | Baseline and Week 12 | This outcome measure was not assessed due to lack of a valid assay during the usable time period of the samples. | ||
| SECONDARY | Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations. | Baseline, Week 12 and 36 | This outcome measure was not assessed due to lack of a valid assay for measuring BLyS and APRIL. | ||
| SECONDARY | Pharmacogenetics/Pharmacogenomics Analysis | Day 1 and Week 36 | Genetic/genomic analysis was not performed as the trial was terminated early. | ||
| PRIMARY | Number of Subjects With Positive Neutralizing Antibody (NAb) | Baseline, Week 12 and 36 | Appropriate method/test was not established to identify the positive neutralizing antibodies for atacicept. Hence, this outcome measure was not assessed. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT00853762/outcomes