Trial · NCT05092776
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 | Proportion of subjects with complete response during 16 week therapy with RPH-104 vs. placebo in FMF subjects with colchicine inefficacy or intolerance. | Up to 16 weeks | Complete response defined as resolution of "marker" attack by Visit 2 (Day 7) and lack of recurrent attacks during the treatment period up to Visit 10 (Day 112). Criteria of resolution of a "marker" FMF attack include simultaneous clinical and laboratory signs of the attack resolution: * Physician Global Assessment (PGA) score \< 2 (i.e. minimum or complete lack of clinical signs and symptoms) AND * C-reactive protein (CRP) level ≤ 10 mg/L OR CRP reduction by ≥ 70% compared to baseline defined at enrollment to treatment period (Visit 1). Criteria of a recurrent FMF attack development after resolution of "marker" attack include simultaneous development of clinical and laboratory signs of the attack: * PGA score ≥ 2 assuming mild, moderate or severe disease activity (i.e. clinical signs), AND * CRP level ≥ 30 mg/L (serological signs). PGA is a 5-point scale: from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Time to the development of a recurrent FMF attack in patients with resolved "marker" attacks | from Day 7 to the development of a recurrent FMF attack, up to 16 weeks | Criteria of a recurrent FMF attack development after resolution of "marker" attack include simultaneous development of clinical and laboratory signs of the attack: * PGA score ≥ 2 assuming mild, moderate or severe disease activity (i.e. clinical signs), AND * CRP level ≥ 30 mg/L (serological signs). PGA is a 5-point scale: from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Proportion of subjects with Physician Global Assessment (PGA) score < 2 during the study | Up to 16 weeks | PGA score \< 2 during the treatment period with RPH-104 compared to placebo in FMF subjects with colchicine inefficacy or intolerance. PGA is a 5-point scale from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Proportion of subjects with partial response to treatment | Up to 16 weeks | Partial response defined as Resolution of "marker" attack by Visit 2 (Day 7) but with development of recurrent attacks up to Visit 10 (Day 112). Criteria of resolution of a "marker" FMF attack include simultaneous clinical and laboratory signs of the attack resolution: * Physician Global Assessment (PGA) score \< 2 (i.e. minimum or complete lack of clinical signs and symptoms) AND * CRP level ≤ 10 mg/L OR CRP reduction by ≥ 70% compared to baseline defined at enrollment to treatment period (Visit 1). Criteria of a recurrent FMF attack development after resolution of "marker" attack include simultaneous development of clinical and laboratory signs of the attack: * PGA score ≥ 2 assuming mild, moderate or severe disease activity (i.e. clinical signs), AND * CRP level ≥ 30 mg/L (serological signs). PGA is a 5-point scale: from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Proportion of subjects with serological remission | Up to 16 weeks | Proportion of subjects with serological remission (CRP ≤ 10 mg/L) throughout the study. |
| Secondary | Proportion of subjects with normalized Serum Amyloid A (SAA) level | Up to 16 weeks | Proportion of subjects with normalized serum amyloid A level (SAA \< 10 mg/L) throughout the study |
| Secondary | Proportion of subjects escalated to RPH-104 160 mg q2w dose | Up to 16 weeks | In patients whose treatment group has been unblinded because of a confirmed attack or no "marker" attack resolution: the patients from RPH-104 group and those switching from placebo and receiving RPH-104 at 80 mg dose will be escalated to RPH-104 160 mg q2w. |
| Secondary | Proportion of subjects receiving additional symptomatic therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs), paracetamol or glucocorticoids due to FMF | Up to 16 weeks | Proportion of subjects receiving additional symptomatic therapy with NSAIDs, paracetamol or glucocorticoids due to FMF |
| Secondary | Change in inflammation parameters vs. baseline (CRP) | From baseline (Day 0) up to 18 weeks | Change in CRP levels vs. baseline (Day 0) |
| Secondary | Change in inflammation parameters vs. baseline (SAA) | From baseline (Day 0) up to 18 weeks | Change in SAA levels vs. baseline (Day 0) |
| Secondary | PGA score change compared to baseline | From baseline (Day 0) up to 18 weeks | PGA score change compared to baseline (Day 0) during the study. PGA is a 5-point scale from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Changes in patients' quality of life during the treatment period with RPH-104 | From baseline (Day 0) up to 18 weeks | Change in quality of life vs. baseline (Day 0) based on Medical Outcome Short Form (12) Health Survey (SF-)12® questionnaire throughout the study. |
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.
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GET https://conductscience.org/api/trials/v1/NCT05092776/registered