Trial · NCT07190196
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 | Time to first adjudicated clinical disease flare treated by the investigator during the Blinded Treatment period | Until Week 52 | The Adjudication Committee will include internationally recognized independent experts in diagnosis and management of patients with IgG4-RD, blinded to participant, investigator, and site identifiers |
| Secondary | Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids and immunomodulators | At Week 52 | |
| Secondary | Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids | At Week 52 | |
| Secondary | Annualized rate of clinical disease flares | At Week 52 | |
| Secondary | Change in IgG4-RD RI total activity scores from baseline to Week 52 | From baseline to Week 52 | |
| Secondary | Proportion of participants in complete remission at Week 52 | At Week 52 | Defined by an IgG4-RD RI total activity score = 0 or absence of evident disease activity assessed by the Investigator |
| Secondary | Percent change in IgG4-RD RI total activity scores from baseline to Week 52 | From baseline to Week 52 | |
| Secondary | Change in IgG4-RD RI total activity scores from baseline to Week 12 | From baseline to Week 12 | |
| Secondary | Percent change in IgG4-RD RI total activity scores from baseline at Week 12 | From baseline to Week 12 | |
| Secondary | Proportion of participants with reduction of ≥2 points from the baseline IgG4-RD RI total activity score | At Week 12, Week 24, and Week 52 | |
| Secondary | Cumulative glucocorticoid dose for treatment of IgG4-RD | At Week 52 | |
| Secondary | Proportion of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population | Until Week 160 | |
| Secondary | Proportion of participants with TEAEs, AESIs, SAEs in the Safety Population | Until Week 160 |
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/NCT07190196/registered