Trial · NCT07570316
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A | Up to 24 weeks (part A) | Free triiodothyronine: \[fT3\]; free thyroxine: \[fT4\]; ATDs: antithyroid drugs |
| Secondary | Time to becoming euthyroid off ATDs in part A | Up to 24 weeks (part A) | ATDs: antithyroid drugs |
| Secondary | Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day at week 24 in part A | Up to 24 weeks (part A) | MMI: methimazole (also known as thiamazole); CBZ: carbimazole. |
| Secondary | Percentage of participants with fT3 and fT4 levels below the ULN off ATDs at week 24 in part A | Up to 24 weeks (part A) | ULN : upper limit of normal; ATDs: antithyroid drugs. |
| Secondary | Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A | Up to 24 weeks (part A) | TRAb: anti-TSHR autoantibodies; ATDs: antithyroid drugs. |
| Secondary | Time to becoming euthyroid off ATDs and TRAb seronegative | Up to 24 weeks (part A) + up to 135 weeks | ATDs: antithyroid drugs; TRAb: anti-TSHR autoantibodies. |
| Secondary | Time to becoming euthyroid and receiving an ATD dose of MMI ≤5 mg/day or CBZ ≤7.5 mg/day (part A) | Up to 24 weeks (Part A) | ATDs: antithyroid drugs; MMI: methimazole (also known as thiamazole); CBZ: carbimazole. |
| Secondary | Time to becoming euthyroid | Up to 24 weeks (part A) + up to 135 weeks | |
| Secondary | Time to having TSH within normal ranges among participants who have TSH lower than the LLN at baseline (part A) | Up to 24 weeks (part A) | TSH: thyroid-stimulating hormone; LLN: lower limit of normal. |
| Secondary | Percentage of participants who remain euthyroid without ATDs | Up to 74 weeks (part B) | ATDs: antithyroid drug |
| Secondary | Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months | Up to 74 weeks (part B) + up to 135 weeks | ATDs: antithyroid drug |
| Secondary | Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS | Up to 72 weeks (part C) | ATDs: antithyroid drug |
| Secondary | Incidence of AEs and SAEs | Up to 135 weeks | AEs: adverse events ; SAEs: serious adverse events. |
| Secondary | Change in ThyPRO-39 over time | Up to 135 weeks | The Thyroid-Specific Patient-Reported Outcome Short Form (ThyPRO-39) 39 item version of the ThyPRO. Each item is related to a specific aspect of the participant's experience with their thyroid condition. Each item is scored on a 5-point Likert scale, and the scores are then transformed to a 0-to-100 scale. Higher scores indicate worse health status. |
| Secondary | Change in PROMIS-PF10a over time | Up to 135 weeks | The Patient-Reported Outcomes Measurement Information System Physical Function-10 item (PROMIS-PF10a) is a self-administered physical functioning assessment comprising 10 items that measure respondents' ability to perform common physical tasks. Scoring involves summing the numerical responses to each item; higher scores indicate better physical function. |
| Secondary | Efgartigimod serum concentrations over time | Up to 24 weeks (part A) + 72 weeks (part C) | |
| Secondary | Percentage change from baseline in total IgG levels in serum over time | Up to 98 weeks | IgG: immunoglobulin G |
| Secondary | Percentage change from baseline in TRAb serum levels over time | Up to 135 weeks | TRAb: anti-TSHR autoantibodies. |
| Secondary | Incidence of ADA against efgartigimod in serum | Up to 24 weeks (part A) + up to 135 weeks | ADA: antidrug antibody(ies) |
| Secondary | Incidence of antibodies against rHuPH20 in plasma | Up to 24 weeks (part A) + Up to 135 weeks | rHuPH20: recombinant human hyaluronidase PH20 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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