Trial · NCT03265132
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)
NCT03265132, Phase 3, Terminated, Swedish Orphan Biovitrum; results first posted 2020-04-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD). Trials, record NCT03265132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03265132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)
- NCT number
- NCT03265132
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 13 participants, actual
- Lead sponsor
- Swedish Orphan Biovitrum
- Conditions
- Still's Disease, Adult-Onset, Still's Disease, Juvenile-Onset
- Interventions
- anakinra, Placebo
- First posted
- 2017-08-29
- Last updated
- 2021-06-30
- Results first posted
- 2020-04-28
Source ClinicalTrials.gov
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2. | Week 2 | ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. (ACR: American College of Rheumatology) 1. Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm). 2. Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm). 3. Number of joints with active arthritis. 4. Number of joints with limitation of motion. 5. Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ). 6. C-Reactive Protein (CRP) (mg/L). |
| Secondary | Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of Responders in Physician Global Assessment of Disease Activity. | Week 2 | Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here. |
| Secondary | Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being. | Week 2 | Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here. |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 registered outcomesOutcomes50
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2. | Week 2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Responders in Physician Global Assessment of Disease Activity. | Week 2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being. | Week 2 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2. | Anakinra | 6 | Participants | ||
| Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2. | Placebo | 0 | Participants | ||
| Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Anakinra | 5 | Participants | ||
| Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Placebo | 3 | Participants | ||
| Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Anakinra | 5 | Participants | ||
| Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Placebo | 2 | Participants | ||
| Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Anakinra | 5 | Participants | ||
| Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Placebo | 0 | Participants | ||
| Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Anakinra | 4 | Participants | ||
| Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Placebo | 0 | Participants |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anakinra | 6 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Anakinra | 6 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Anakinra | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events58
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 | Upper respiratory infection | Infections and infestations | Anakinra | 3 | 6 | 3 |
| other | Upper respiratory infection | Infections and infestations | Placebo | 0 | 6 | 0 |
| other | Ear infection | Infections and infestations | Anakinra | 1 | 6 | 1 |
| other | Ear infection | Infections and infestations | Placebo | 0 | 6 | 0 |
| other | Urinary tract infection | Infections and infestations | Anakinra | 0 | 6 | 0 |
| other | Urinary tract infection | Infections and infestations | Placebo | 1 | 6 | 1 |
| other | Viral upper respiratory tract infection | Infections and infestations | Anakinra | 1 | 6 | 1 |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo | 0 | 6 | 0 |
| other | Anxiety | Psychiatric disorders | Anakinra | 1 | 6 | 1 |
| other | Anxiety | Psychiatric disorders | Placebo | 0 | 6 | 0 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anakinra | 0 | 6 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Anakinra | 6 | 6 |
| Total, other adverse events | Placebo | 4 | 6 |
| Total, serious adverse events | Anakinra | 0 | 6 |
| Total, serious adverse events | Placebo | 1 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons28
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anakinra vs Placebo: Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ). | Trial comparisons |
| Anakinra vs Placebo: Proportion of Patients With Macrophage Activation Syndrome (MAS). | Trial comparisons |
| Anakinra vs Placebo: Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Trial comparisons |
| Anakinra vs Placebo: Proportion of Patients With Absence of Rash. | Trial comparisons |
| Anakinra vs Placebo: Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Trial comparisons |
| Anakinra vs Placebo: Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2. | Trial comparisons |
| Anakinra vs Placebo: Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2. | Trial comparisons |
| Anakinra vs Placebo: Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being. | Trial comparisons |
| Anakinra vs Placebo: Proportion of Patients With Inactive Disease. | Trial comparisons |
| Anakinra vs Placebo: Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2. | Trial comparisons |
1 to 10 of 28
See all 28 trial comparisonsTests0
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/NCT03265132
GET https://conductscience.org/api/trials/v1/NCT03265132/registered?page=2