Trial · NCT07598396
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants who have achieved remission by Week 76 | Up to Week 76 | Drug-Free Remission is defined as achieving both of the following: Absence of disease activity maintained for 6 months after completion of mosunetuzumab treatment, and; not receiving any SLE-directed therapy (except for antimalarials) during the 6 months. Doses of prednisone (or equivalent) ≤5 mg/day to treat secondary adrenal insufficiency are permitted. |
| Secondary | Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76 | Up to Week 76 | DORIS remission is defined as achievement of all of the following for at least 6 months: Clinical systemic lupus erythematosus disease activity index (cSLEDAI) = 0 after completion of mosunetuzumab treatment; stable dosing of SLE therapies for at least 6 months; Physician Global Assessment (PGA) of \< 0.5, and; prednisone (or equivalent) dose ≤5 mg/day. |
| Secondary | Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104 | Weeks 24, 52, 76, and 104 | CRR is defined as all of the following: Urinary protein-to-creatinine ratio (UPCR) \< 0.5 g/g, and; estimated glomerular filtration rate (eGFR) ≥ 85% of baseline, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or ≥ 60 ml/min per 1.73 m\^2 of body-surface area. |
| Secondary | Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104 | Weeks 24, 52, 76, and 104 | PRR is defined as all of the following: ≥ 50% reduction in UPCR from baseline; UPCR \< 1 g/g (or \< 3 g/g if the baseline UPCR was ≥ 3 g/g), and; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation. |
| Secondary | Percentage of participants with adverse events (AEs) | Up to 2.5 years | |
| Secondary | Longitudinal change in titers of anti-double-stranded (ds) DNA | Up to 2.5 years | |
| Secondary | Longitudinal changes in complement C3 and C4 | Up to 2.5 years | |
| Secondary | Serum concentration of mosunetuzumab | Up to 2.5 years | |
| Secondary | Percentage of participants with anti-drug antibodies (ADAs) | Baseline up to 2.5 years | |
| Secondary | CD19+ absolute counts in blood | Up to 2.5 years | |
| Secondary | Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue | Baseline to Week 76 | |
| Secondary | Change in Subject's Global Assessment of Disease Activity (SGA) | Baseline to Week 76 |
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/NCT07598396/registered