Trial · NCT06508021
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of New HO Lesions as Assessed by WBCT-LH [Whole body, Computerized Tomography (CT), not including the head (less head)] | Week 27 and 53 | Low dose WBCT-LH (whole body CT less head) is used to create detailed images of soft tissues and bones. |
| Secondary | Percent change from baseline in Na18F standardized uptake value maximum (SUVmax) of up to 7 individual HO lesion(s) per participant active at baseline as assessed by Na18F PET/CT (Part 1a). | Week 14 | SUV max is the SUV of the most intense voxel within a region of interest. |
| Secondary | Change in HO volume over time as assessed by WBCT-LH [Whole body, Computerized Tomography (CT), not including the head (less head)] (Part 1a) | Week 14 | Low dose WBCT-LH (whole body CT less head) is used to create detailed images of soft tissues and bones. In Part 1a, the WBCT-LH scan will be acquired as part of the PET/CT scan at baseline and Week 14. |
| Secondary | Change in HO volume over time as assessed by WBCT-LH [Whole body, Computerized Tomography (CT), not including the head (less head)] | Week 27 and 53 | |
| Secondary | Number of days during which a flare-up is experienced by the participant as reported by the participant | Week 14, 27 and 53 | Flare-up defined as having at least two of the following symptoms: pain, soft tissue swelling, warmth, redness, joint stiffness, or decreased range of motion. |
| Secondary | Number of flare-ups as reported by the participant | Week 14, 27 and 53 | |
| Secondary | Number of flare-ups as reported by the participant and confirmed by the Principal Investigator | Week 14, 27 and 53 | |
| Secondary | Change in patient joint involvement as assessed by Investigator using Cumulative Analog Joint Involvement Scale (CAJIS) | Week 27 and 53 | CAJIS is a clinician assessment of 15 major joints; each major joint rated normal unaffected (0), affected (1), or completely functionally ankylosed (2). The total score ranges from 0 to 30. |
| Secondary | Change in patient quality of life as assessed by the EuroQol 5 dimensions questionnaire with a 5-level scale (EQ-5D-5L) | Week 27 and 53 | EQ-5D-5L measures: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Week 27 and 53 | Number of participants with Treatment-Emergent Adverse Events (AE) (TEAEs), i.e., adverse events not present at baseline or exacerbation of a pre-existing condition during the on-treatment period will be reported. |
| Secondary | Number of Participants With Serious Treatment-Emergent Adverse Events (Serious TEAEs) | Week 27 and 53 | Number of participants with Serious Treatment-Emergent Adverse Events (AE) (TEAEs), i.e, required initial/prolonged in-patient hospitalization, death, life-threatening, persistent/significant disability/incapacity, congenital anomaly/birth defect, considered as a medically important event. |
| Secondary | Number of Participants With TEAEs by Severity | Week 27 and 53 | Severity of TEAEs will be graded as follows: Mild: Does not interfere in a significantly with functioning. Moderate: Causes some impairment of functioning but is not hazardous to health. Severe: Significant impairment or incapacitation; hazardous to one's health. Number of participants with TEAEs by severity will be reported. |
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
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