Trial · NCT00582907
Rilonacept for Treatment of Familial Mediterranean Fever (FMF)
NCT00582907, Phase 2, Completed, The Cleveland Clinic; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rilonacept for Treatment of Familial Mediterranean Fever (FMF). Trials, record NCT00582907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00582907
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rilonacept for Treatment of Familial Mediterranean Fever (FMF)
- NCT number
- NCT00582907
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Familial Mediterranean Fever
- Interventions
- Rilonacept, Placebo
- First posted
- 2007-12-28
- Last updated
- 2013-02-11
- Results first posted
- 2012-10-31
- Limitations and caveats
1. Small sample size - accounted for in study design and analysis plan.~2. Carry over/lag effect of rilonacept - sensitivity analysis of shifting course time frame showed similar results.~3. Heterogeneity of FMF mutations~4. Different age groups
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. | attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each) | Difference in number of attacks per treatment month between rilonacept and placebo |
| Primary | To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. | 12 months of entire study length | Differences in adverse events (AEs) between rilonacept and placebo per patient-month of treatment. We separately analyzed injection site reactions and infectious adverse events. Other adverse events were too small in number to analyze. The upper table (and first statistical analysis) regards injection site reactions and lower table (and second statistical analysis) regards infections. |
| Secondary | To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo. | 12 months | This outcome was the difference in days in the length of attacks between rilonacept and placebo. |
| Secondary | Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses. | Each treatment course of up to 3 months | The percentage of rilonacept and placebo treatment courses without FMF attacks. |
| Secondary | To Determine the Proportion of Courses in Which Subjects Attained at Least a 50% Decrease in Acute FMF Attacks During Rilonacept Courses as Compared to Placebo Courses. | Up to 3 months for each treatment course | Differences between rilonacept and placebo in the percentage of courses that attained at least a 50% decrease in FMF attacks when compared to attacks in the screening period. |
| Secondary | To Determine Differences in the Time to the Development of Attacks Between the Treatment Arms (Rilonacept vs. Placebo). | 3 months | In a survival analysis we measured the difference (in days) until the development of the first and second attack within a treatment course of up to 3 months and examined differences in this parameter between rilonacept and placebo. Data regarding the development of the second attack are reported below. In regards to the first attack there were no significant differences between rilonacept and placebo (20 days (7.5,\>90)for rilonacept; 15 (8,32) for placebo, P=0.066). |
| Secondary | To Determine the Differences in the Erythrocyte Sedimentation Rate Between the Treatment Arms (Rilonacept vs. Placebo). | 3 months (each treatment course, overall 12 months) | Erythrocyte sedimentation rate - ESR (mm/h) |
| Secondary | To Determine the Differences in C-Reactive Protein Between the Treatment Arms (Rilonacept vs. Placebo) | 3 months (each treatment course, overall 12 months) | Differences between the treatment courses in the C-Reactive Protein levels mg/L |
| Secondary | To Determine the Differences in the Platelet Count Between the Treatment Arms (Rilonacept vs. Placebo) | 3 months (each treatment course, overall 12 months) | The difference between the treatment arms in the platelet count X 10 to the power of 9 |
| Secondary | To Determine the Differences in the Fibrinogen Levels Between the Treatment Arms (Rilonacept vs. Placebo) | 3 months (each treatment course, overall 12 months) | The differences between treatment arms in the fibrinogen level (micromol/L) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. | attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each) | Patients who received at least one complete treatment course and reported attacks were analyzed for the primary outcome measure. | number of attacks per month | MEDIAN |
| PRIMARY | To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. | 12 months of entire study length | Safety analysis included all participants who received at least one dose of medication. | AEs per patient-month of treatment | MEDIAN |
| SECONDARY | To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo. | 12 months | Participants who received any treatment and had recorded attacks | Number of days | MEDIAN |
| SECONDARY | Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses. | Each treatment course of up to 3 months | Participants who at least one complete treatment course. | Percentage of courses | NUMBER |
| SECONDARY | To Determine the Proportion of Courses in Which Subjects Attained at Least a 50% Decrease in Acute FMF Attacks During Rilonacept Courses as Compared to Placebo Courses. | Up to 3 months for each treatment course | Participants who completed at least one complete treatment course. | Percentage of courses | NUMBER |
| SECONDARY | To Determine Differences in the Time to the Development of Attacks Between the Treatment Arms (Rilonacept vs. Placebo). | 3 months | All participants who received an intervention and developed an attack were analyzed. | days until second attack | MEDIAN |
| SECONDARY | To Determine the Differences in the Erythrocyte Sedimentation Rate Between the Treatment Arms (Rilonacept vs. Placebo). | 3 months (each treatment course, overall 12 months) | Participants who completed at least one treatment course of both rilonacept and placebo. | mm/h | MEDIAN |
| SECONDARY | To Determine the Differences in C-Reactive Protein Between the Treatment Arms (Rilonacept vs. Placebo) | 3 months (each treatment course, overall 12 months) | Patients who received at least one course each of rilonacept and placebo | mg/L | MEDIAN |
| SECONDARY | To Determine the Differences in the Platelet Count Between the Treatment Arms (Rilonacept vs. Placebo) | 3 months (each treatment course, overall 12 months) | The number of patients who received at least one course each of rilonacept and placebo | cell count X10 to the power of 9 | MEDIAN |
| SECONDARY | To Determine the Differences in the Fibrinogen Levels Between the Treatment Arms (Rilonacept vs. Placebo) | 3 months (each treatment course, overall 12 months) | Patients who received at least one course each of rilonacept and placebo | micromol/L | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. | Rilonacept | 0.77 | Inter-Quartile Range 0.18 to 1.20 | number of attacks per month | |
| To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. | Placebo | 2.00 | Inter-Quartile Range 0.90 to 2.40 | number of attacks per month | |
| To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. | Rilonacept | Injection site reactions | 1 | Inter-Quartile Range 0 to 1.04 | AEs per patient-month of treatment |
| To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. | Placebo | Injection site reactions | 0 | Inter-Quartile Range 0 to 0.36 | AEs per patient-month of treatment |
| To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. | Rilonacept | Infections | 0 | Inter-Quartile Range 0 to 0.12 | AEs per patient-month of treatment |
| To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. | Placebo | Infections | 0.18 | Inter-Quartile Range 0 to 0.29 | AEs per patient-month of treatment |
| To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo. | Rilonacept | 2.8 | 95% Confidence Interval 1 to 3.3 | Number of days | |
| To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo. | Placebo | 3.2 | 95% Confidence Interval 2.7 to 4 | Number of days | |
| Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses. | Rilonacept | 29 | Percentage of courses | ||
| Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses. | Placebo | 0 | Percentage of courses |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1st Course | STARTED | Rilonacept-Placebo-Rilonacept-Placebo | 4 | |
| 1st Course | STARTED | Rilonacept-Placebo-Placebo-Rilonacept | 3 | |
| 1st Course | STARTED | Placebo-Rilonacept-Placebo-Rilonacept | 3 | |
| 1st Course | STARTED | Placebo-Rilonacept-Rilonacept-Placebo | 4 | |
| 1st Course | COMPLETED | Rilonacept-Placebo-Rilonacept-Placebo | 3 | |
| 1st Course | COMPLETED | Rilonacept-Placebo-Placebo-Rilonacept | 3 | |
| 1st Course | COMPLETED | Placebo-Rilonacept-Placebo-Rilonacept | 3 | |
| 1st Course | COMPLETED | Placebo-Rilonacept-Rilonacept-Placebo | 3 | |
| 1st Course | NOT COMPLETED | Rilonacept-Placebo-Rilonacept-Placebo | 1 | |
| 1st Course | NOT COMPLETED | Rilonacept-Placebo-Placebo-Rilonacept | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | Injury, poisoning and procedural complications | Placebo | 5 | 14 | 13 |
| other | Injection site reaction | Injury, poisoning and procedural complications | Rilonacept | 7 | 13 | 53 |
| other | Upper respiratory infection/Otitis | Infections and infestations | Placebo | 3 | 14 | 3 |
| other | Upper respiratory infection/Otitis | Infections and infestations | Rilonacept | 0 | 13 | 0 |
| other | Sinusitis | Infections and infestations | Placebo | 1 | 14 | 1 |
| other | Sinusitis | Infections and infestations | Rilonacept | 1 | 13 | 1 |
| other | Herpes labialis | Infections and infestations | Placebo | 1 | 14 | 1 |
| other | Herpes labialis | Infections and infestations | Rilonacept | 0 | 13 | 0 |
| other | Herpes Zoster | Infections and infestations | Placebo | 1 | 14 | 1 |
| other | Herpes Zoster | Infections and infestations | Rilonacept | 0 | 13 | 0 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Rilonacept | ||
| Total, other adverse events | Placebo | 12 | 14 |
| Total, other adverse events | Rilonacept | 11 | 13 |
| Total, serious adverse events | Placebo | 3 | 14 |
| Total, serious adverse events | Rilonacept | 3 | 13 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003435 | Phase II, IL-1 Trap for Treatment of Familial Mediterranean Fever | SPALDING, STEVEN J | CLEVELAND CLINIC FOUNDATION | FOOD AND DRUG ADMINISTRATION | 2007 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rilonacept vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00582907
GET https://conductscience.org/api/trials/v1/NCT00582907/results?page=2