Trial · NCT03188666
Outcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
21 to 40 of 43
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Period 2 vs. Period 1: Change From Week 28 in Number of Active HO Lesions as Assessed by 18^F-NaF PET to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Active lesions | MEAN |
| SECONDARY | Period 2 vs. Period 1: Change From Week 28 in Number of Active HO Lesions as Assessed by CT Scan at Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan is collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Active lesions | MEAN |
| SECONDARY | Period 2: Number of New HO Lesions as Assessed by CT at Week 56 Relative to Baseline (AHO COVID-19 mITT) | Baseline, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 only (Placebo/REGN2477) as planned. | New HO Lesions | NUMBER |
| SECONDARY | Period 2: Number of New HO Lesions as Assessed by CT Only at Week 56 Relative to Baseline (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who receive a treatment in Period 2 for whom at least 1 post-Week 28 scan is collected and the period between any consecutive doses is less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | New HO Lesions | NUMBER |
| SECONDARY | Period 2: Percentage of Participants With New HO Lesions as Assessed by CT at Week 56 Relative to Baseline (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | Percentage of Participants | NUMBER |
| SECONDARY | Period 2: Number of New HO Lesions as Assessed by 18^F-NAF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | New HO Lesions | NUMBER |
| SECONDARY | Period 2: Percentage of Participants With New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | Percentage of Participants | NUMBER |
| SECONDARY | Period 2: Total Volume of New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | cubic centimeter (cm^3) | MEAN |
| SECONDARY | Period 2: Total Lesion Activity (TLA) Assessed by 18^F-NaF PET in New HO Lesions at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | gram (g) | MEAN |
| SECONDARY | Period 2 vs. Period 1: Percent Change From Week 28 in TLA as Assessed by 18^F-NaF PET to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Percent Change | MEAN |
| SECONDARY | Period 2 vs. Period 1: Percent Change From Week 28 in the Total Volume of HO Lesions as Assessed by CT to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Percent Change | MEAN |
| SECONDARY | Period 2: TLA in New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | gram (g) | MEAN |
| SECONDARY | Period 2: Total Volume of New HO Lesions as Assessed by CT Only at Week 56 Relative to Baseline (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | cubic centimeter (cm^3) | MEAN |
| SECONDARY | Period 2: Percent Change From Baseline in TLA as Assessed by 18^F-NaF PET to Week 56 (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | Percent Change | MEAN |
| SECONDARY | Period 2: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT to Week 56 (AHO COVID-19 mITT) | Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | Percent Change | MEAN |
| SECONDARY | Period 2: Percent Change From Week 28 in SUVmax as Assessed by 18^F-NaF to Week 56 (AHO COVID-19 mITT) | Week 28 to Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | Percent Change | MEAN |
| SECONDARY | Period 2: Percent Change From Baseline in 18^F-NaF PET SUVmax to Week 56 (AHO COVID-19 mITT) | Baseline, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned. | Percent Change | MEAN |
| SECONDARY | Period 2: Daily Average Pain Due to FOP Measured Using the Daily NRS | Week 28 up to Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Data were planned to be collected and analyzed only for participants switching to REGN2477 in period 2 for this outcome measure. | Score on a Scale | MEAN |
| SECONDARY | Period 2: Percentage of Participants With Flare-ups Assessed by Participant E-diary | Week 28 to Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Data were planned to be collected and analyzed only for participants switching to REGN2477 in period 2 for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Period 2: Percentage of Participants With Investigator-assessed Flare-ups | Week 28 to Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Data were planned to be collected and analyzed only for participants switching to REGN2477 in period 2 for this outcome measure. | Percentage of Participants | NUMBER |
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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