Trial · NCT04354649
Immune-Mediated Pathophysiology And Clinical Triage Program
NCT04354649, Phase 2, Recruiting, AHS Cancer Control Alberta
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immune-Mediated Pathophysiology And Clinical Triage Program. Trials, record NCT04354649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04354649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immune-Mediated Pathophysiology And Clinical Triage Program
- NCT number
- NCT04354649
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 46 participants, estimated
- Lead sponsor
- AHS Cancer Control Alberta
- Conditions
- Arthritis, Arthralgia
- Interventions
- Hydroxychloroquine, Placebo
- First posted
- 2020-04-21
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence of grade ≥2 Immune-Related Arthritis or Arthralgia | Through study completion, an average of 1 year | Recurrence will be defined as the development of grade ≥2 irAA in a participant whose symptoms initially improved to grade ≤1. Symptoms will be investigator assessed and graded according to CTCAEv5.0. |
| Secondary | Total Steroid Usage | Through study completion, an average of 1 year | The total cumulative dose of prednisone measured in mg used by the participant. If corticosteroids other than prednisone are used, their equivalent dosage in mg of prednisone will be calculated and used for this analysis. |
| Secondary | Development of immune related adverse events (irAE's) other than irAA | Through study completion, an average of 1 year | Defined as the emergence of adverse events that were not present at study baseline that are deemed by the investigator to be related to prior use of immune checkpoint inhibitors. Causality will be investigator assessed and graded according to CTCAEv5.0. |
| Secondary | Adverse Event | Through study completion, an average of 1 year | The emergence of new or worsening baseline symptoms, physical findings, or laboratory/imaging abnormalities. Causality to study treatment, immune checkpoint inhibitors, or underlying disease status will be investigator assessed and graded according to CTCAEv5.0. |
| Secondary | Re-initiation of immune checkpoint inhibitor therapy | Through study completion, an average of 1 year | The proportion of participants in each study arm that are re-treated with an immune checkpoint inhibitor. |
| Secondary | Response to standard of care treatments after Week 13 Day 1. | From Week 13 Day 1 to Week 52. | Participants that still have active irAA symptoms of CTCAEv5.0 grade ≥1 after unblinding at Week 13 Day 1 visit who have a change in irAA therapy. |
| Secondary | Progression free survival | Upon completion of follow-up period, an average of 3 years after intervention | The time elapsed between randomization and tumor progression (radiographically or clinically) or death from any cause. |
Source ClinicalTrials.gov
Outcomes0
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/NCT04354649
GET https://conductscience.org/api/trials/v1/NCT04354649/registered