Trial · NCT07902492
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the superiority of rituximab over azathioprine for maintenance therapy in patients with primary angiitis of central nervous system | 24 month | To compare the efficacy of rituximab versus azathioprine in maintaining remission in patients with primary angiitis of the central nervous system (PACNS), based on the occurrence of clinical and/or radiological relapse during follow-up. Relapse is assessed using clinical evaluation and brain MRI findings according to the study protocol. |
| Secondary | Proportion of participants without relapse at 12 and 24 months | Month 12 and Month 24 | Proportion of participants who remain free from PACNS relapse at 12 and 24 months after randomization. Relapse is defined according to the clinical and/or radiological criteria specified in Section 4.1.1 of the protocol. |
| Secondary | Proportion of participants without "clinical relapse" (i.e. new neurological symptoms attributable to active PACNS) at 12 and 24 months (see definition in section 4.1.1 of the protocol) | Month 12 and Month 24 | Proportion of participants without clinical relapse at 12 and 24 months. Clinical relapse is defined as the occurrence of new neurological symptoms attributable to active primary angiitis of the central nervous system (PACNS), according to the definition provided in Section 4.1.1 of the protocol. |
| Secondary | Proportion of participants without "radiological relapse" (i.e. worsening of existing or evidence of new abnormal neuroimaging findings on MRI consistent with PACNS activity) at 12 and 24 months | Month 12 and Month 24 | Proportion of participants without radiological relapse at 12 and 24 months. Radiological relapse is defined as worsening of pre-existing neuroimaging abnormalities or the occurrence of new MRI abnormalities consistent with active primary angiitis of the central nervous system (PACNS), according to the definition provided in Section 4.1.1 of the protocol. |
| Secondary | Proportion of participants without evidence of new stroke lesion at 12 and 24 months | Month 12 and Month 24 | Proportion of participants with no evidence of new stroke lesions on brain MRI at 12 and 24 months compared with baseline imaging. |
| Secondary | Proportion of participants without evidence of new contrast-enhanced lesions at 12 and 24 months | Month 12 and Month 24 | Proportion of participants with no evidence of new contrast-enhancing lesions on brain MRI at 12 and 24 months compared with baseline imaging. |
| Secondary | Proportion of participants without evidence of new intracranial stenosis on proximal cerebral arteries at 12 and 24 months. | Month 12 and Month 24 | Proportion of participants with no evidence of new intracranial stenosis involving the proximal cerebral arteries on brain vascular imaging at 12 and 24 months compared with baseline imaging. |
| Secondary | Proportion of participants without evidence of progression ≥ 50% of preexisting intracranial stenosis at 12 and 24 months. | Month 12 and Month 24 | Proportion of participants with no evidence of progression of pre-existing intracranial stenosis by 50% or more on brain vascular imaging at 12 and 24 months compared with baseline. |
| Secondary | Proportion of participants necessitating treatment change or escalation at 12 and 24 months | Month 12 and Month 24 | Proportion of participants requiring a change or escalation of maintenance therapy due to suspected or confirmed PACNS disease activity during follow-up, including treatment modification, intensification, or initiation of additional immunosuppressive therapy. |
| Secondary | Proportion of participants with favorable outcome defined as mRS < 3 at 12 and 24 months | Month 12 and Month 24 | Proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of less than 3, at 12 and 24 months. |
| Secondary | SF-36 at 12 and 24 months | Month 12 and Month 24 | Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36) at 12 and 24 months. |
| Secondary | Prednisone dosage at 12 and 24 months | Month 12 and Month 24 | Daily prednisone dose, expressed in mg/day, at 12 and 24 months to assess corticosteroid exposure during maintenance therapy. |
| Secondary | The number of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading system at 12 and 24 months | From randomization to Month 12 and Month 24 | Number of adverse events occurring during the study, classified according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading system. |
| Secondary | Proportion of death | From randomization to Month 24 | Proportion of participants who die from any cause during the study follow-up period. |
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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