Trial · NCT01441076

Anakinra for Behcet s Disease

NCT01441076, Phase 1, Phase 2, Completed, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); results first posted 2017-05-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Anakinra for Behcet s Disease. Trials, record NCT01441076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01441076

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Trial

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

Title: Anakinra for Behcet s Disease
NCT number: NCT01441076
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 6 participants, actual
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions: Autoimmune Connective Tissue Disorder, Immune System Diseases
Interventions: Anakinra
First posted: 2011-09-27
Last updated: 2017-05-12
Results first posted: 2017-05-12

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Clinical Remission From Months 3-6	Monthly study visits from months 3-6 during the trial	Clinical remission was defined as no oral or vaginal ulcers on physical examination for 2 consecutive monthly visits from months 3-6.
Secondary	Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score	Month 6 study visit	The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.
Secondary	Behcet's Syndrome Activity Scale (BSAS) Score	Month 6 study visit	The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.
Secondary	Behcets Disease Current Activity Form (BDCAF) Score	Month 6 study visit	The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.
Secondary	Number of Genital Ulcers by Physician Evaluation	Month 6 study visit	Number of genital ulcers noted by physician evaluation
Secondary	Number of Oral Ulcers by Physician Evaluation	Month 6 study visit	Number of oral ulcers noted by physician evaluation
Secondary	Patient Global Score	Month 6 study visit	Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.
Secondary	Physician Global Score	Month 6 study visit	Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.
Secondary	Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score	Baseline	The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.
Secondary	Behcet's Syndrome Activity Scale (BSAS) Score	Baseline	The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Remission From Months 3-6	Monthly study visits from months 3-6 during the trial	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Participants	NUMBER
SECONDARY	Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score	Month 6 study visit	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Units on a scale	MEDIAN
SECONDARY	Behcet's Syndrome Activity Scale (BSAS) Score	Month 6 study visit	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Units on a scale	MEDIAN
SECONDARY	Behcets Disease Current Activity Form (BDCAF) Score	Month 6 study visit	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Units on a scale	MEDIAN
SECONDARY	Number of Genital Ulcers by Physician Evaluation	Month 6 study visit	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	genital ulcers in participants	MEDIAN
SECONDARY	Number of Oral Ulcers by Physician Evaluation	Month 6 study visit	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	oral ulcers in participants	MEDIAN
SECONDARY	Patient Global Score	Month 6 study visit	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Units on a scale	MEDIAN
SECONDARY	Physician Global Score	Month 6 study visit	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Units on a scale	MEDIAN
SECONDARY	Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score	Baseline	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Units on a scale	MEDIAN
SECONDARY	Behcet's Syndrome Activity Scale (BSAS) Score	Baseline	Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.	Units on a scale	MEDIAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group15

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

Outcome	Group	Value	Spread	Units
Clinical Remission From Months 3-6	Anakinra	2		Participants
Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score	Anakinra	9.5	Full Range 0 to 22	Units on a scale
Behcet's Syndrome Activity Scale (BSAS) Score	Anakinra	21.3	Full Range 0 to 44	Units on a scale
Behcets Disease Current Activity Form (BDCAF) Score	Anakinra	5	Full Range 4 to 6	Units on a scale
Number of Genital Ulcers by Physician Evaluation	Anakinra	0	Full Range 0 to 0	genital ulcers in participants
Number of Oral Ulcers by Physician Evaluation	Anakinra	0.5	Full Range 0 to 2	oral ulcers in participants
Patient Global Score	Anakinra	51.5	Full Range 3 to 91	Units on a scale
Physician Global Score	Anakinra	8.5	Full Range 7 to 24	Units on a scale
Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score	Anakinra	16	Full Range 10 to 24	Units on a scale
Behcet's Syndrome Activity Scale (BSAS) Score	Anakinra	46	Full Range 22 to 80.5	Units on a scale

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Anakinra	6
Overall Study	COMPLETED	Anakinra	4
Overall Study	NOT COMPLETED	Anakinra	2

Source ClinicalTrials.gov

Adverse events27

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	Anemia	Blood and lymphatic system disorders	Anakinra	1	6
other	Blurred vision	Eye disorders	Anakinra	1	6
other	Eye disorders - Other, specify	Eye disorders	Anakinra	1	6
other	Abdominal pain	Gastrointestinal disorders	Anakinra	2	6
other	Edema limbs	General disorders	Anakinra	2	6
other	Fatigue	General disorders	Anakinra	1	6
other	Allergic reaction	Immune system disorders	Anakinra	4	6
other	Bronchial Infection	Infections and infestations	Anakinra	1	6
other	Infections and infestations - Other, specify	Infections and infestations	Anakinra	1	6
other	Pharyngitis	Infections and infestations	Anakinra	1	6

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Anakinra
Total, other adverse events	Anakinra	6	6
Total, serious adverse events	Anakinra	1	6

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12032915	BACKGROUND	PubMed
12483741	BACKGROUND	PubMed
17393462	BACKGROUND	PubMed
28335798	DERIVED	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.

GET https://conductscience.org/api/trials/v1/NCT01441076

GET https://conductscience.org/api/trials/v1/NCT01441076/events?page=2

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