Trial · NCT00853762
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | TEAEs were defined as AEs with a start date after or on the date of the first DB treatment injection in ATAMS Extension and that occurred anytime after treatment discontinuation, or up to the day before first Rebif® rescue medication injection in ATAMS Extension. A serious TEAE was an AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE severity was graded as per Qualitative Toxicity Scale. Local injection site reactions (injection site: pain, redness, itching and swelling) throughout ATAMS Extension, starting after the first trial medication administration. If the subject experienced 1 or more of the above injection site symptoms, these were reported with the AE verbatim term "injection site reaction". For all randomized subjects, there was an option of rescue treatment with Rebif® for 1 year beginning with the first injection of Rebif®). |
| 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 | Blood pressure (systolic and diastolic) was measured after at least 3 minutes resting, with the subject in the seated position. |
| Primary | Change From Baseline in Vital Signs: Pulse Rate | Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 | |
| Primary | Change From Baseline in Vital Signs: Temperature | Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36 | |
| Primary | Change From Baseline in Electrocardiogram (ECGs) | Baseline, Week 12 and 36 | |
| Primary | Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels | Baseline up to Week 36 | Number of subjects with shifts from normal Grade (Grade 0) at Baseline to worse value at post-baseline (Grade 1 to Grade 4) according to the following criteria: IgA Grade 0: greater than or equal to (\>=) lower limit normal (LLN) 0.7 gram per liter (g/L); Grade 1: less than (\<) LLN - 0.5 g/L, Grade 2: \<0.5g/L -0.3 g/L, Grade 3: \<0.3 g/L -0.1 g/L, Grade 4: \< 0.1 g/L; IgG Grade 0: \>= LLN (7 g/L), Grade 1: \< LLN - 5 g/L, Grade 2: \<5g/L -4 g/L, Grade 3: \<4 g/L -3 g/L and Grade 4: \< 3 g/L; IgM Grade 0: \>= LLN (0.4 g/L), Grade 1: \< LLN - 0.3 g/L, Grade 2: \<0.3 g/L -0.2 g/L, Grade 3: \<0.2 g/L -0.1 g/L, and Grade 4: \< 0.1 g/L are presented in this outcome measure. |
| Primary | Number of Subjects With Positive Neutralizing Antibody (NAb) | Baseline, Week 12 and 36 | |
| Secondary | Number of Subjects With Clinical Attacks/Relapses | Baseline up to Week 24 | A clinical attack/relapse was defined as the fulfillment of all the following criteria: 1. 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. 2. Absence of fever or known infection (fever with temperature (axillary, orally, or intra-auriculary) \> 37.5°C/99.5 °Fahrenheit). 3. Objective neurological impairment, correlating with the subject'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. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. |
| Secondary | Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12 | Baseline, Week 12 | EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. |
| Secondary | Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12 | Week 12 | The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3). |
| Secondary | Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject | Baseline, Week 12 and 24 | |
| Secondary | Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject | Baseline, Week 12 and Week 24 | |
| Secondary | Concentrations of Free and Total Atacicept | Baseline and Week 12 | |
| Secondary | Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations. | Baseline, Week 12 and 36 | Levels of free APRIL and free BLyS: Free APRIL serum samples were to be analyzed by using a validated enzyme-linked immunosorbent assay (ELISA) with limits of detection of 0.3125 nanogram per milliliter (ng/mL) for free APRIL and free BlyS serum samples were analysed using a validated ELISA with limits of detection of 1.56 ng/mL. |
| Secondary | Pharmacogenetics/Pharmacogenomics Analysis | Day 1 and Week 36 | Gene expression profiling and gene polymorphism identification were to be used to identify putative markers for response to treatment. * Genome-wide gene polymorphism characterization by genome-wide scan. * Targeted gene polymorphism identification of B-Lymphocyte Stimulator (BLyS) , APRIL, (receptor for B cell activating factor of the tumor necrosis factor \[TNF\] family) BAFF-R, (Transmembrane Activator) TACI and (B Cell Maturation Antigen) BCMA and HLA-DRB1 by direct genotyping or sequencing . |
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.
For software
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