Trial · NCT02204293

Canakinumab for Treatment of Adult-onset Still's Disease

NCT02204293, Phase 2, Terminated, Charite University, Berlin, Germany; results first posted 2020-08-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Canakinumab for Treatment of Adult-onset Still's Disease. Trials, record NCT02204293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02204293

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Canakinumab for Treatment of Adult-onset Still's Disease
NCT number: NCT02204293
Status: Terminated
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Charite University, Berlin, Germany
Conditions: Adult-Onset Still´s Disease
Interventions: Canakinumab, Placebo
First posted: 2014-07-30
Last updated: 2020-08-07
Other registries' IDs: eudract:2011-001027-20
Results first posted: 2020-08-07
Limitations and caveats: The study terminated prior to the planned completion date due to recruitment issues because of the marketing authorization of the study drug.

Source ClinicalTrials.gov

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12	Week 12	Responders included participants with change in disease activity score based on 28 joint counts and ESR (DAS28) score \> 1.2. The DAS28 score index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and the erythrocyte sedimentation rate (ESR) value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \< 2.6 = disease remission.
Secondary	Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Baseline, Weeks 4, 8 and 12	The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and ESR value.Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \< 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Least squares (LS) mean was calculated by mixed linear model for repeated measures (MMRM) analyses.
Secondary	Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score	Baseline, Weeks 4, 8 and 12	The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \< 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.
Secondary	Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)	Baseline, Weeks 4, 8 and 12	The 68 TJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no tender joint) to 68 (all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.
Secondary	Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)	Baseline, Weeks 4, 8 and 12	The 66 SJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no swollen joint) to 66 (all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. A negative change in Baseline indicates improvement. LS mean was calculated by MMRM analyses.
Secondary	Core Study Part I: CFB in the 28 TJC	Baseline, Weeks 4, 8 and 12	A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.
Secondary	Core Study Part I: CFB in the 28 SJC	Baseline, Weeks 4, 8 and 12	A total of 28 joints were assessed for swelling. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.
Secondary	Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP	Baseline, Weeks 4, 8 and 12	A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.
Secondary	Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR	Baseline, Weeks 4, 8 and 12	A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.
Secondary	Core Study Part I: CFB in Serum Ferritin Level at Week 12	Week 12	LS mean was calculated by MMRM analyses.

1 to 10 of 27Source ClinicalTrials.gov

See all 27 registered outcomes

Outcomes27

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12	Week 12	Intention-to-treat (ITT) population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.	percentage of participants	NUMBER
SECONDARY	Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	tender joints	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	swollen joints	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in the 28 TJC	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	tender joints	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in the 28 SJC	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	swollen joints	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	milligrams per liter (mg/L)	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR	Baseline, Weeks 4, 8 and 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	millimeter per hour (mm/h)	LEAST_SQUARES_MEAN
SECONDARY	Core Study Part I: CFB in Serum Ferritin Level at Week 12	Week 12	ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.	nanograms per milliliter (ng/mL)	LEAST_SQUARES_MEAN

1 to 10 of 27Source ClinicalTrials.gov

See all 27 outcomes

Results by group148

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12	Core Study Part I: Canakinumab		66.7	95% Confidence Interval 43.1 to 85.2	percentage of participants
Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12	Core Study Part I: Placebo		41.2	95% Confidence Interval 20.1 to 65.0	percentage of participants
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Canakinumab	Baseline	5.37	95% Confidence Interval 4.7 to 6.0	score on a scale
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Placebo	Baseline	5.3	95% Confidence Interval 4.6 to 6.0	score on a scale
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Canakinumab	CFB at Week 4	3.56	95% Confidence Interval 2.9 to 4.3	score on a scale
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Placebo	CFB at Week 4	4.27	95% Confidence Interval 3.5 to 5.0	score on a scale
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Canakinumab	CFB at Week 8	2.86	95% Confidence Interval 2.2 to 3.6	score on a scale
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Placebo	CFB at Week 8	3.92	95% Confidence Interval 3.1 to 4.7	score on a scale
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Canakinumab	CFB at Week 12	3.1	95% Confidence Interval 2.4 to 3.8	score on a scale
Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score	Core Study Part I: Placebo	CFB at Week 12	4.0	95% Confidence Interval 3.3 to 4.8	score on a scale

1 to 10 of 148Source ClinicalTrials.gov

See all 148 results by group

Participant flow72

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Core Study Part I	STARTED	Core Study Part I: Canakinumab	19
Core Study Part I	STARTED	Core Study Part I: Placebo	17
Core Study Part I	STARTED	Core Study Part II: Canakinumab Responders	0
Core Study Part I	STARTED	Core Study Part II: Placebo Responders	0
Core Study Part I	STARTED	Core Study Part II: Placebo Non-responders	0
Core Study Part I	STARTED	LTE Phase: Canakinumab	0
Core Study Part I	Intention-to-treat Population	Core Study Part I: Canakinumab	18
Core Study Part I	Intention-to-treat Population	Core Study Part I: Placebo	17
Core Study Part I	Intention-to-treat Population	Core Study Part II: Canakinumab Responders	0
Core Study Part I	Intention-to-treat Population	Core Study Part II: Placebo Responders	0

1 to 10 of 72Source ClinicalTrials.gov

See all 72 participant flow

Adverse events480

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
other	Lymphadenopathy	Blood and lymphatic system disorders	Core Study Part I: Canakinumab	0	20
other	Lymphadenopathy	Blood and lymphatic system disorders	Core Study Part I: Placebo	0	15
other	Lymphadenopathy	Blood and lymphatic system disorders	Core Study Part II: Canakinumab Responders	0	14
other	Lymphadenopathy	Blood and lymphatic system disorders	Core Study Part II: Placebo Responders	0	2
other	Lymphadenopathy	Blood and lymphatic system disorders	Core Study Part II: Placebo Non-responders	1	7
other	Lymphadenopathy	Blood and lymphatic system disorders	LTE Phase: Canakinumab	0	7
other	Eyelid oedema	Eye disorders	Core Study Part I: Canakinumab	2	20
other	Eyelid oedema	Eye disorders	Core Study Part I: Placebo	0	15
other	Eyelid oedema	Eye disorders	Core Study Part II: Canakinumab Responders	0	14
other	Eyelid oedema	Eye disorders	Core Study Part II: Placebo Responders	0	2

1 to 10 of 480Source ClinicalTrials.gov

See all 480 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Core Study Part I: Canakinumab	0	20
Total, all-cause mortality	Core Study Part I: Placebo	0	15
Total, all-cause mortality	Core Study Part II: Canakinumab Responders	0	14
Total, all-cause mortality	Core Study Part II: Placebo Responders	0	2
Total, all-cause mortality	Core Study Part II: Placebo Non-responders	0	7
Total, all-cause mortality	LTE Phase: Canakinumab	0	7
Total, other adverse events	Core Study Part I: Canakinumab	16	20
Total, other adverse events	Core Study Part I: Placebo	10	15
Total, other adverse events	Core Study Part II: Canakinumab Responders	13	14
Total, other adverse events	Core Study Part II: Placebo Responders	2	2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26589963	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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