Trial · NCT07880886
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum serum concentration of goflikicept (Cmax (W16)) | Visit 1 (Baseline) to Visit 10 (Week 16) | |
| Primary | Area under serum concentration-time curve for goflikicept (AUC(0-W16)) | Visit 1 (Baseline) to Visit 10 (Week 16) | |
| Secondary | Changes in trough serum goflikicept concentration | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Trough serum steady-state concentration of goflikicept (Cmin,ss) | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Area under curve for the dosing interval (t) at steady state (ss) after repeated injections (AUC0-t,ss) | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Time to steady state | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Percentage of participants with a complete response to treatment | Up to Visit 16 (Week 56) | Complete response is defined as resolution of a "marker" familial Mediterranean fever (FMF) attack by day 7 and the absence of recurrent (new) attacks during the treatment period. |
| Secondary | Change from baseline in PGA (Physician Global Assessment) score | at Visit 1 (Baseline) and Visit 16 (Week 56) | The Physician's Global Assessment (PGA) is an investigator-rated 5-point scale used to evaluate overall disease activity. Scores range from 0 to 4, where: 0 = none; 1 = minimum; 2 = mild; 3 = moderate; 4 = severe signs and symptoms. Higher scores indicate greater disease severity. |
| Secondary | Change from baseline in C-reactive protein (CRP) level | at Visit 1 (Baseline) and Visit 16 (Week 56) | |
| Secondary | Change from baseline in serum amyloid A (SAA) level | at Visit 1 (Baseline) and Visit 16 (Week 56) | |
| Secondary | Percentage of participants with serological remission (C-reactive protein < 10 mg/L) | Up to Visit 16 (Week 56) | Serological remission is defined as a C-reactive protein (CRP) level of less than 10 mg/L. |
| Secondary | Time to a recurrent (new) FMF attack in participants with a resolved "marker" attack | Visit 2 (Week 1) to Visit 16 (Week 56) | Recurrent (new) Familial Mediterranean Fever (FMF) attack is defined as the presence of both clinical and serological signs of an attack after resolution of the "marker" attack. |
| Secondary | Percentage of participants who were administered an increased dose of goflikicept 2.2 mg/kg once every 2 weeks | Up to Visit 16 (Week 56) | |
| Secondary | Frequency, Severity, Nature, and Outcomes of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Visit 16 (Week 56) | Adverse event (AE) severity is assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. |
| Secondary | Percentage of participants with anti-drug antibodies (ADA) | Up to Visit 16 (Week 56) | |
| Secondary | Number of participants with clinically significant laboratory abnormalities | Up to Visit 16 (Week 56) | Laboratory parameters include: * Hematology * Blood Biochemistry * Measurement of the concentration of immunoglobulin type G (IgG) * Urinalysis |
| Secondary | Number of participants with clinically significant vital sign abnormalities | Up to Visit 16 (Week 56) | Measurement of vital signs includes: * body temperature (in degrees Celsius) * blood pressure (BP) (one arm, mm Hg) * heart rate (HR) (bpm) * respiratory rate (RR) (per min) |
| Secondary | Percentage of participants with Physician Global Assessment (PGA) score < 2 at each visit | Up to Visit 16 (Week 56) | The Physician's Global Assessment (PGA) is an investigator-rated 5-point scale used to evaluate overall disease activity. Scores range from 0 to 4, where: 0 = none; 1 = minimum; 2 = mild; 3 = moderate; 4 = severe signs and symptoms. Higher scores indicate greater disease severity. |
| Secondary | Сhange from baseline in the overall disease activity assessed by the participant/parent (Visual analogue scale) | at Visit 1 (Baseline) and Visit 16 (Week 56) | Assessment of the disease activity by the subject/legal representative is performed using a visual analog scale (VAS) in mm (0-100), where 0 mm = very good, 100 mm = very bad. |
| Secondary | Percentage of participants with a partial response | Up to Visit 16 (Week 56) | Partial response is defined as resolution of a "marker" familial Mediterranean fever (FMF) attack by day 7 and the presence of recurrent (new) attacks during the treatment period. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07880886/registered