Trial · NCT05791708
Cold Agglutinin Disease Real World Evidence Registry
NCT05791708, Active not recruiting, RECORDATI GROUP
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cold Agglutinin Disease Real World Evidence Registry. Trials, record NCT05791708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05791708
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cold Agglutinin Disease Real World Evidence Registry
- NCT number
- NCT05791708
- Status
- Active not recruiting
- Enrollment
- 429 participants, actual
- Lead sponsor
- RECORDATI GROUP
- Conditions
- Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
- Interventions
- Sutimlimab
- First posted
- 2023-03-30
- Last updated
- 2026-04-22
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patterns of CAD and CAS disease characteristics | Up to 6 years | CAD or CAS characteristics at diagnosis, enrollment, and during follow up (e.g., criteria used for diagnosis, symptoms, laboratory results) will be described. |
| Primary | Number of participants with CAD or CAS complications | Up to 6 years | Thromboembolic events (venous, arterial or cerebral), deaths related to CAD or CAS, other CAD/CAS complications (e.g., acute hemolytic crisis, hemolysis-related complications), and other comorbid conditions occurring before enrollment, at enrollment, and during follow up will be described. |
| Primary | Patterns of use of CAD and CAS treatments | Up to 6 years | CAD or CAS treatments received before enrollment, at enrollment, and during the follow up period will be summarized. CAD or CAS symptoms and complications, autoimmune disorders or lymphoproliferative disorders, physician assessment of treatment status, and changes in laboratory results will be described by CAD or CAS treatments. |
| Primary | Number of participants with health-resource utilization | Up to 6 years | Health resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits, nursing home/rehabilitation center stays, and home healthcare visits during registry follow-up period |
| Primary | Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ) | Up to 6 years | |
| Primary | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Up to 6 years | |
| Primary | 36-Item Short Form Survey Instrument (SF-36) v2 | Up to 6 years | |
| Primary | Sutimlimab cohort: Sutimlimab treatment patterns | Up to 6 years | Sutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described. |
| Primary | Sutimlimab cohort: Number of participants with adverse events, serious adverse events, adverse events of special interests (AESIs), other events of interests (e.g., Treatment emergent) | Up to 6 years | |
| Primary | Sutimlimab cohort: change from baseline in hemoglobin | From baseline up to 6 years |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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/NCT05791708
GET https://conductscience.org/api/trials/v1/NCT05791708/registered