Trial · NCT02808429
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | percentage of participants | NUMBER |
| 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 | 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 safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | gram per liter | MEAN |
| 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 safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | gram per liter | MEAN |
| 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 safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | gram per liter | MEAN |
| 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 safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | nanogram per milliliter (ng/mL) | MEAN |
| 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 safety population set (SAF) consisted of all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Number of participants analyzed signifies participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable for specified category. | milligram per liter | MEAN |
| 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 | Flow Cytometry (FC) Set: all participants in SAF set who were part of the selected sites for FC analysis and who had at least 1 sample taken for FC analysis. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure. and number analyzed signifies those participants who were evaluable for specified category. | cells per microliter | MEAN |
| 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) | As per changed in planned analysis the outcome measure related to Urinary Immunoglobulins was not assessed. | ||
| SECONDARY | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Baseline up to safety follow-up (96 weeks) | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments | Baseline up to safety follow-up (96 weeks) | As per changed in planned analysis the outcome measure related to clinically significant abnormalities in laboratory assessments was not assessed. | ||
| SECONDARY | Percentage of Participants With Clinical Significant Abnormalities in Vital Signs | Baseline up to safety follow-up (96 weeks) | As per changed in planned analysis the outcome measure related to clinically significant abnormalities in vital signs was not assessed. | ||
| SECONDARY | Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | Baseline up to safety follow-up (96 weeks) | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | percentage of participants | NUMBER |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02808429/outcomes