Trial · NCT02808429
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Baseline up to 96 weeks | Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that developed or worsened/became serious during on-treatment period (time from the first dose of study drug up to the end of study \[Week 96\]). TEAEs included serious AEs and non- serous AEs. AESIs included infections, cardiac failure, cardiomyopathy/ ischemic heart disease, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching). |
| Secondary | Serum Atacicept Concentrations | Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24 | Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. |
| Secondary | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 | The change in serum levels of IgA from baseline was reported. |
| Secondary | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 | The change in serum levels of IgG from baseline was reported. |
| Secondary | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24 | The change in serum levels of IgM from baseline was reported. |
| Secondary | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24 | The change in serum Gd-IgA1 from baseline was reported. |
| Secondary | Change From Baseline in Serum Complement C3 and C4 Levels | Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24 | The change in serum component C3 and C4 from baseline were reported. |
| Secondary | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24 | Change from baseline in immune cell subsets included total T cells, helper T cells, cytotoxic T cells, total B cells (assay with \[AW\] CD45 or assay without \[AWO\] CD45), mature naïve B cells, memory B cells, plasma cells, plasma blasts, and natural killer (NK) cells and were reported. Analysis was performed by flow cytometry analysis. |
| Secondary | Change From Baseline in Urinary IgG, IgA, and IgM Levels | Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72) | Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis. |
| Secondary | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Baseline up to safety follow-up (96 weeks) | Percentage of participants with positive ADA were reported. |
| Secondary | Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments | Baseline up to safety follow-up (96 weeks) | Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator. |
| Secondary | Percentage of Participants With Clinical Significant Abnormalities in Vital Signs | Baseline up to safety follow-up (96 weeks) | Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, weight and height. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator. |
| Secondary | Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | Baseline up to safety follow-up (96 weeks) | 12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The number of participants with clinically significant abnormalities in 12-lead ECG were reported. |
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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