Trial · NCT07902492
Efficacy of Rituximab for Remission Maintenance in Patients With Primary Angiitis of the Central Nervous System: an Open-label, Randomized, Controlled Trial Comparing Systematic Rituximab Infusions and Azathioprine
NCT07902492, Phase 2, Not yet recruiting, Centre Hospitalier St Anne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Rituximab for Remission Maintenance in Patients With Primary Angiitis of the Central Nervous System: an Open-label, Randomized, Controlled Trial Comparing Systematic Rituximab Infusions and Azathioprine. Trials, record NCT07902492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07902492
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy of Rituximab for Remission Maintenance in Patients With Primary Angiitis of the Central Nervous System: an Open-label, Randomized, Controlled Trial Comparing Systematic Rituximab Infusions and Azathioprine
- NCT number
- NCT07902492
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 74 participants, estimated
- Lead sponsor
- Centre Hospitalier St Anne
- Conditions
- Primary Angiitis of the Central Nervous System (PACNS) in Remission
- Interventions
- RUXIENCE®., Brain MRI, Azathioprine 50 MG
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07902492
GET https://conductscience.org/api/trials/v1/NCT07902492/registered