| 1 |
NCT03446209 |
Not yet recruiting |
Tocilizumab for the Treatment of Familial Mediterranean Fever |
- Familial Mediterranean Fever
|
- Drug: Tocilizumab Infusion RoAcemtra (EU)
- Drug: 0.9% physiological saline
|
Interventional |
Phase 2 |
- University Hospital Tuebingen
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Efficacy: measured change of Physician's Global Assessment of disease activity (PGA)
- Incidence of Treatment-Emergent Adverse Events-Determination of Erytthro Sedimentation Rate (ESR)
- serological remission
- SAA level
|
30 |
All |
18 Years to 64 Years (Adult) |
NCT03446209 |
TOFFIFE 1.1 |
|
March 1, 2018 |
November 30, 2019 |
April 30, 2020 |
February 26, 2018 |
February 26, 2018 |
|
- University Hospital Tuebingen; Department of oncology, hematology, rheumatology, immunology and pulmology
Tuebingen, Germany
|
| 2 |
NCT02175589 |
Unknown † |
Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation |
- Familial Mediterranean Fever
|
- Other: Colchicine Cessation
|
Interventional |
Phase 2 |
- Rambam Health Care Campus
- Schneider Children's Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Acute clinical episode of FMF
- High level of Serum Amyloid A (SAA) in serum
|
80 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02175589 |
0080-14-RMB |
|
June 2014 |
January 2015 |
January 2015 |
June 26, 2014 |
June 26, 2014 |
|
- Pediatric rheumatology clinic, Rambam Medical Center
Haifa, Israel - Schneider children's hospital
Petach Tikva, Israel
|
| 3 |
NCT01705756 |
Completed |
Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever |
- Familial Mediterranean Fever
|
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of patients with less than a mean of one FMF attack per month
- Number of serious adverse events
|
25 |
All |
18 Years to 65 Years (Adult) |
NCT01705756 |
SHEBA-11-8557-AL-CTIL |
FMF |
November 2012 |
December 2014 |
June 2015 |
October 12, 2012 |
July 21, 2017 |
|
- Sheba Medical Center
Tel- Hashomer, Ramat- Gan, Israel
|
| 4 |
NCT01088880 |
Completed |
Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever |
- Familial Mediterranean Fever
|
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period.
- To assess the effect of canakinumab with regard to percentage of patients with no attacks in month 3.
- To find the optimal dose of canakinumab for FMF in this population
- (and 3 more...)
|
10 |
All |
12 Years to 75 Years (Child, Adult, Senior) |
NCT01088880 |
CACZ885DTR01 |
|
April 2010 |
August 2011 |
August 2011 |
March 17, 2010 |
May 1, 2012 |
|
- Istanbul Medical Faculty, Dept of Rheumatology, Capa
Istanbul, Turkey
|
| 5 |
NCT00582907 |
Completed
Has Results |
Rilonacept for Treatment of Familial Mediterranean Fever (FMF) |
- Familial Mediterranean Fever
|
- Drug: Rilonacept
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks.
- To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo.
- To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo.
- (and 11 more...)
|
14 |
All |
4 Years and older (Child, Adult, Senior) |
NCT00582907 |
1R01FD003435-01
FDA 1RO1FD003435-01 |
|
August 2008 |
September 2011 |
September 2011 |
December 28, 2007 |
February 11, 2013 |
October 31, 2012 |
- Children's Hospital Los Angeles/Cedars-Sinai Medical Center
Los Angeles, California, United States - Children's Hospital of Central California
Madera, California, United States - NIH
Bethesda, Maryland, United States - (and 2 more...)
|
| 6 |
NCT00323440 |
Withdrawn |
Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission |
- Familial Mediterranean Fever
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT00323440 |
SHEBA-06-4126-AL-CTIL |
|
August 2008 |
August 2010 |
August 2016 |
May 9, 2006 |
October 11, 2017 |
|
- Sheba Medical Center
Tel Hashomer, Israel
|
| 7 |
NCT02602028 |
Completed |
The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF |
- Familial Mediterranean Fever
|
|
Interventional |
Phase 4 |
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Mor severity scoring system
- Adverse events
- Number of Participants With Abnormal Laboratory Values
|
79 |
All |
5 Years to 16 Years (Child) |
NCT02602028 |
1491-1437-11/1539 |
|
April 2011 |
April 2013 |
August 2013 |
November 11, 2015 |
November 11, 2015 |
|
- FMF Arthritis Vasculitis and Orphan Disease Research in Paediatric Rheumatology (FAVOR)
Ankara, Turkey
|
| 8 |
NCT01148797 |
Completed |
Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF) |
- Colchicine Resistant/Intolerant Familial Mediterranean Fever
|
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To measure the effect of canakinumab on the frequency of FMF attacks, defined as percentage of subjects with at least 50% reduction in the attack frequency during a 3 month treatment period
- To assess the effect of canakinumab with regard to percentage of subjects with no attacks during the 3 months treatment period
- To evaluate the safety and tolerability of canakinumab by monitoring adverse events (AEs) and subject discontinuations due to an AE
- To assess the change in frequency of FMF attacks during the treatment period
|
15 |
All |
4 Years to 20 Years (Child, Adult) |
NCT01148797 |
CACZ885D2204 |
CONTROL FMF |
December 2010 |
February 2012 |
|
June 22, 2010 |
November 18, 2016 |
|
- Rambam Health Care Campus
Haifa, Israel - Shaare Zedek Medical Center
Jerusalem, Israel - Meir Medical Center Kfar Saba
Kfar Saba, Israel - (and 2 more...)
|
| 9 |
NCT02021084 |
Withdrawn |
The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. |
- Familial Mediterranean Fever (FMF )
|
- Dietary Supplement: probiotic
- Dietary Supplement: Placebo
|
Interventional |
Not Applicable |
- Rambam Health Care Campus
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The number of gastrointestinal adverse effect related to colchicine therapy after adding probiotics to colchicine therapy.
- Number of FMF attacks after adding the probiotics to the colchicine therapy
|
0 |
All |
5 Years to 18 Years (Child, Adult) |
NCT02021084 |
0173-13-RMB CTIL |
|
December 2013 |
December 2014 |
December 2014 |
December 27, 2013 |
October 7, 2016 |
|
|
| 10 |
NCT01075906 |
Completed |
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients |
- Familial Mediterranean Fever
|
- Drug: colchicine sprinkle capsules
|
Interventional |
Phase 1 |
- Mutual Pharmaceutical Company, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Maximum Plasma Concentration
- Area Under the Concentration Time Curve from Time Zero to the Time of Last Measured Concentration (AUC 0-t)
- Area Under the Concentration Time Curve from Zero through Infinity
- Acute Phase Reactant (ESR, CRP, SAA) Levels
|
75 |
All |
2 Years to 65 Years (Child, Adult) |
NCT01075906 |
MPC-006-09-1001 |
|
August 2010 |
December 2011 |
December 2011 |
February 25, 2010 |
January 10, 2012 |
|
- Childrens Hospital Los Angeles
Los Angeles, California, United States - Center of Medical Genetics and Primary Health Care
Yerevan, Armenia - Soroka Medical Center
Beer Sheba, Israel - (and 7 more...)
|
| 11 |
NCT00658060 |
Unknown † |
Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients |
- Familial Mediterranean Fever
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- change in spectroscopic appearance of muscle after exertion of muscle thigh
- change in muscle intensity signal after exertion
- change in joint effusion status after exertion
|
20 |
All |
18 Years to 45 Years (Adult) |
NCT00658060 |
SHEBA-07-4632-IE-CTIL |
|
September 2007 |
|
|
April 14, 2008 |
April 14, 2008 |
|
- Sheba Medical Center
Ramat Gan, Israel
|
| 12 |
NCT00001373 |
Recruiting |
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics |
- Familial Mediterranean Fever (FMF)
|
|
Observational |
|
- National Human Genome Research Institute (NHGRI)
- University of Massachusetts, Worcester
- Duke University
- (and 2 more...)
|
NIH / Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
199998 |
All |
Child, Adult, Senior |
NCT00001373 |
940105
94-HG-0105 |
|
March 10, 1994 |
|
|
November 4, 1999 |
April 24, 2018 |
|
- Childrens National Medical Center
Washington, District of Columbia, United States - Johns Hopkins University
Baltimore, Maryland, United States - Walter Reed National Medical Center
Bethesda, Maryland, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 13 |
NCT02059291 |
Active, not recruiting
Has Results |
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers |
- Hereditary Periodic Fevers
|
- Drug: Canakinumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16weeks)
- Percentage of Participants Who Achieve Physician's Global Assessment < 2
- Percentage of Participants With the Serologic Remission
- Percentage of Participants With Normalized Serum Amyloid A (SAA) Level
|
204 |
All |
1 Month and older (Child, Adult, Senior) |
NCT02059291 |
CACZ885N2301 |
|
June 28, 2014 |
August 25, 2015 |
June 28, 2017 |
February 11, 2014 |
May 18, 2017 |
March 17, 2017 |
- Novartis Investigative Site
Los Angeles, California, United States - Novartis Investigative Site
Ann Arbor, Michigan, United States - Novartis Investigative Site
Cleveland, Ohio, United States - (and 62 more...)
|
| 14 |
NCT02911857 |
Completed |
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes |
|
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number and percentage of patients with adverse events
|
4 |
All |
Child, Adult, Senior |
NCT02911857 |
CACZ885N2301E2 |
|
October 3, 2016 |
January 27, 2017 |
January 27, 2017 |
September 22, 2016 |
May 12, 2017 |
|
- Novartis Investigative Site
Fukuoka city, Fukuoka, Japan - Novartis Investigative Site
Yokohama-city, Kanagawa, Japan - Novartis Investigative Site
Kyoto-city, Kyoto, Japan
|
| 15 |
NCT02775994 |
Unknown † |
Ilaris (Canakinumab) in Patient With Periodic Fever, Aphthous Stomatitis, Pharyngitis and Cervical Adenitis (PFAPA) |
|
|
Interventional |
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in average number of flares - documented by the use of diary
- Time to flare - documented by the use of diary
- Change in quality of life - documented by the use of questionnaire
|
10 |
All |
2 Years to 10 Years (Child) |
NCT02775994 |
0032-16-RMC |
|
June 2016 |
January 2017 |
March 2017 |
May 18, 2016 |
May 20, 2016 |
|
|
| 16 |
NCT02334748 |
Active, not recruiting |
A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies |
- Systemic Juvenile Idiopathic Arthritis
- Hereditary Periodic Fevers
|
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
31 |
All |
Child, Adult, Senior |
NCT02334748 |
CACZ885GFR01 |
|
November 3, 2014 |
December 22, 2018 |
December 22, 2018 |
January 8, 2015 |
February 23, 2018 |
|
- Novartis Investigative Site
Bron Cedex, France - Novartis Investigative Site
Le Kremlin Bicetre, France - Novartis Investigative Site
Paris, France
|
| 17 |
NCT03210610 |
Recruiting |
Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients |
- FMF
- Colchicine Resistance
- Colchicine Toxicity
|
- Diagnostic Test: colchicine level measurement
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT03210610 |
3997-17-SMC |
|
October 19, 2017 |
July 15, 2020 |
July 15, 2020 |
July 7, 2017 |
April 20, 2018 |
|
- Sheba Medical Center
Ramat Gan, Israel
|
| 18 |
NCT01059279 |
Enrolling by invitation |
Heat Intolerance in the Group of FMF Patients |
- Familial Mediterranean Fever
- Heat Intolerance
- Heat Tolerance Test
|
|
Observational |
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
15 |
Male |
18 Years to 30 Years (Adult) |
NCT01059279 |
SHEBA-09-7575-AL-CTIL |
|
December 2009 |
August 2018 |
December 2018 |
January 29, 2010 |
July 21, 2017 |
|
- Sheba Medical Center
Tel Hashomer., Israel
|
| 19 |
NCT02092064 |
Unknown † |
Association Between Basal Proteinuria Levels and Pregnancy Outcomes in Familial Mediterranean Fever |
- Basal Proteinuria in Pregnancy
|
|
Observational |
|
- Zekai Tahir Burak Women's Health Research and Education Hospital
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- change in proteinuria correlation to the adverse outcomes of pregnancy
|
40 |
Female |
18 Years to 39 Years (Adult) |
NCT02092064 |
Basal Proteinuria in FMF |
|
April 2014 |
October 2014 |
April 2015 |
March 19, 2014 |
March 19, 2014 |
|
- Zekai Tahir Burak Maternity Hospital
Ankara, Altindag, Turkey
|
| 20 |
NCT00094900 |
Completed
Has Results |
Interleukin-1 Trap to Treat Autoinflammatory Diseases |
- Inflammation
- Familial Mediterranean Fever
- Still's Disease, Adult-Onset
|
|
Interventional |
Phase 2 |
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mean Change in Daily Scores
- Mean Change in ESR
- Mean Change in hsCRP
- (and 20 more...)
|
11 |
All |
18 Years and older (Adult, Senior) |
NCT00094900 |
050014
05-AR-0014 |
|
October 2004 |
September 2010 |
December 2010 |
October 28, 2004 |
March 4, 2014 |
July 10, 2013 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 21 |
NCT02535962 |
Withdrawn |
Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA) |
- Periodic Fever
- Aphthous Stomatitis
- Pharyngitis
- Cervical Adenitis
|
- Biological: Lactobacillus acidophilus and Bifidobacterium lactis
- Other: Placebo
|
Interventional |
Phase 2 |
- Connecticut Children's Medical Center
- DuPont Nutrition and Health
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Effects of the investigational treatment
- Safety of the investigational treatment - reported descriptively as percentages of patients experiencing adverse and serious adverse events.
- Maximal fever experienced during a PFAPA febrile episode will be recorded as an average of the peak temperature recorded during each episode throughout the year and compared between the study groups
- (and 3 more...)
|
0 |
All |
1 Year to 12 Years (Child) |
NCT02535962 |
15-017 |
PFAPA |
October 2016 |
September 2017 |
September 2017 |
August 31, 2015 |
January 24, 2018 |
|
|
| 22 |
NCT00260299 |
Unknown † |
Dietary Cholesterol and Defects in Cholesterol Synthesis in Mevalonate Kinase Deficiency |
- Mevalonic Aciduria
- Mevalonate Kinase Deficiency
- Immune System Diseases
- (and 2 more...)
|
|
Observational |
|
- Oregon Health and Science University
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Determine the effects of dietary cholesterol changes in MKD on cholesterol and related synthetic pathways
- Define genotype, phenotype and response to dietary cholesterol. Determine genotype-therapy correlations.
|
15 |
All |
Child, Adult, Senior |
NCT00260299 |
MKD dietary study |
|
February 2005 |
|
December 2012 |
December 1, 2005 |
March 23, 2012 |
|
- Oregon Health & Science University
Portland, Oregon, United States
|
| 23 |
NCT01801449 |
Completed
Has Results |
Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA) |
|
|
Interventional |
Phase 2 |
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Subjects Who Maintained Inflammatory Remission With Rilonacept
- Height
- Weight
- (and 3 more...)
|
6 |
All |
3 Months and older (Child, Adult, Senior) |
NCT01801449 |
130086
13-AR-0086 |
|
February 12, 2013 |
April 28, 2016 |
April 28, 2016 |
February 28, 2013 |
October 16, 2017 |
October 16, 2017 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 24 |
NCT01952275 |
Recruiting |
Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases |
- Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue
- Pyoderma Gangrenosum
- Erosive Pustular Dermatosis of the Scalp
- (and 25 more...)
|
- Procedure: Collection of biological samples
|
Observational |
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Enrichment of rare coding genetic variants
|
600 |
All |
up to 120 Years (Child, Adult, Senior) |
NCT01952275 |
USZ-DER-AAN-019 |
NEUTROGENE |
January 2014 |
January 2020 |
January 2020 |
September 27, 2013 |
September 27, 2016 |
|
- University Hospital Zurich, Dept. of Dermatology
Zurich, ZH, Switzerland
|
| 25 |
NCT01242813 |
Completed
Has Results |
Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS). |
- TNF-receptor Associated Periodic Syndromes (TRAPS)
|
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Complete or Almost Complete Response at Day 15
- Percentage of Participants With Complete or Almost Complete Response at Day 8
- Percentage of Participants With Complete Clinical Remission at Day 8 and 15
- (and 14 more...)
|
20 |
All |
4 Years and older (Child, Adult, Senior) |
NCT01242813 |
CACZ885D2203
2010-020061-24 |
|
October 2010 |
June 2014 |
June 2014 |
November 17, 2010 |
February 4, 2016 |
February 4, 2016 |
- Novartis Investigative Site
Galway, Ireland - Novartis Investigative Site
Sciacca, AG, Italy - Novartis Investigative Site
Brescia, BS, Italy - (and 3 more...)
|
| 26 |
NCT00035334 |
Completed |
Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis |
- Secondary (AA) Amyloidosis
- Rheumatoid Arthritis
- Nephrotic Syndrome
- (and 3 more...)
|
- Drug: NC-503 (Anti-amyloidotic (AA) Agent)
|
Interventional |
Phase 2
Phase 3 |
- Bellus Health Inc
- FDA Office of Orphan Products Development
|
Industry / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT00035334 |
CL-503004 |
|
October 2001 |
|
December 2004 |
May 3, 2002 |
February 14, 2006 |
|
- Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,
Indianapolis, Indiana, United States - Boston Medical Center, Renal Division
Boston, Massachusetts, United States - Mayo Clinic
Rochester, Minnesota, United States - (and 23 more...)
|
| 27 |
NCT02974595 |
Recruiting |
Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still'S-like Diseases, and Other Undifferentiated Autoinflammatory Diseases) |
- NOMID
- CAPS
- DIRA
- (and 4 more...)
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To study the pathogenesis of patients affected with autoinflammatory diseases, including their clinical, immunological, genetic and metabolic-endrocrinological characteristics.
- To collect long-term clinical and laboratory outcome parameters of the multiorgan inflammatory involvement and/or organ damage in patients with genetically defined or undifferentiated autoinflammatory (immune-dysregulatory) diseases.
- To evaluate clinical characteristics-disease manifestations and blood, body fluids, and tissue biomarkers during disease flares and quiescence
|
2200 |
All |
up to 99 Years (Child, Adult, Senior) |
NCT02974595 |
170016
17-I-0016 |
|
November 23, 2016 |
October 20, 2031 |
October 20, 2032 |
November 28, 2016 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 28 |
NCT02326376 |
Active, not recruiting |
Kineret CAPS Post Authorisation Study |
- Cryopyrin-Associated Periodic Syndromes
|
|
Observational |
|
- Swedish Orphan Biovitrum
- Pediatric Rheumatology International Trials Organization
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Rate of serious infections
- Rate of new malignancies
- Rate of injection site reactions
- (and 2 more...)
|
13 |
All |
Child, Adult, Senior |
NCT02326376 |
Sobi.Anakin-201
ENCEPP/SDPP/6366 |
|
April 2015 |
April 2020 |
April 2020 |
December 29, 2014 |
August 24, 2017 |
|
- Swedish Orphan Biovitrum Investigational Site
Lille, France - Swedish Orphan Biovitrum Investigational Site
Paris, France - Swedish Orphan Biovitrum Investigational Site
Groningen, Netherlands - (and 2 more...)
|
| 29 |
NCT01168570 |
Unknown † |
Progression of Renal Amyloidosis of FMF and Relation to Serum SAA Level |
|
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01168570 |
SHEBA-10-7713-AL-CTIL |
|
September 2010 |
September 2016 |
September 2017 |
July 23, 2010 |
August 17, 2010 |
|
- Sheba Medical Center
Tel Hashomer, Israel
|
| 30 |
NCT03374345 |
Recruiting |
Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT) |
|
- Drug: Sipjeondaebo-tang Granule
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Gachon University Gil Oriental Medical Hospital
- Kyunghee University Oriental Medical Center
- Kyung Hee University Hospital at Gangdong
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Changes from baseline in visual analogue scale(VAS)
- Changes from baseline in body temperature
- Changes from baseline in WHO Quality of Life-BREF
- (and 9 more...)
|
60 |
Female |
19 Years to 59 Years (Adult) |
NCT03374345 |
ISEE_2017_SDT |
|
January 31, 2018 |
June 30, 2018 |
June 30, 2018 |
December 15, 2017 |
February 15, 2018 |
|
- Gachon University Gil Hospital
Incheon, Korea, Republic of
|
| 31 |
NCT03083522 |
Recruiting |
Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet |
|
- Drug: Ojeok-San
- Drug: Placebo
|
Interventional |
Phase 3 |
- Chan-Yong Jeon
- Kyunghee University Oriental Medical Center
- Kyung Hee University Hospital at Gangdong
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Changes from baseline in visual analogue scale
- Changes from baseline in body temperature
- Changes from baseline in WHOQoL-BREF
- (and 6 more...)
|
60 |
Female |
19 Years to 59 Years (Adult) |
NCT03083522 |
ISEE_2017_OJS |
OJS |
March 30, 2017 |
December 2018 |
December 2018 |
March 20, 2017 |
April 20, 2018 |
|
- Kyung Hee university medical center
Seoul, Korea, Republic of
|
| 32 |
NCT02645916 |
Completed |
Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands |
|
- Drug: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang
- Drug: Placebo: corn starch
|
Interventional |
Phase 4 |
- Gachon University Gil Oriental Medical Hospital
- Sangji University Oriental Medical Hospital
- Semyung University second affiliated oriental medical hospital at Chungju
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Changes from baseline in visual analogue scale
- Changes from baseline in body temperature
- Changes from baseline in clinical global impression(CGI)
- (and 2 more...)
|
66 |
Female |
19 Years to 59 Years (Adult) |
NCT02645916 |
ISEE_2015_DSGOST |
|
December 2015 |
August 1, 2017 |
August 1, 2017 |
January 5, 2016 |
November 29, 2017 |
|
- Gachon University, Gil Oriental Medicine Center
Incheon, Korea, Republic of
|
| 33 |
NCT01664156 |
Completed |
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet |
|
- Drug: Korean red ginseng
- Drug: Placebo
|
Interventional |
Phase 4 |
- The Korean Society of Ginseng
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The change of the infrared thermography of cold hypersensitivity on hands
- The change of the infrared thermography of cold hypersensitivity on feet
- The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
- (and 4 more...)
|
80 |
Female |
16 Years to 60 Years (Child, Adult) |
NCT01664156 |
KHNMC-OH-IRB 2012-004 |
|
October 2012 |
December 2013 |
March 2014 |
August 14, 2012 |
March 14, 2014 |
|
- Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, Korea, Republic of
|
| 34 |
NCT02466217 |
Recruiting |
Phenomics in Autoimmune and Inflammatory Diseases |
- Healthy Volunteer
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- (and 10 more...)
|
- Other: 1: AID groups
- Other: 2: Control groups
|
Observational |
|
- Assistance Publique - Hôpitaux de Paris
- National Research Agency, France
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Total peripheral blood gene expression between patients, expressed as fluorescence intensity
- Tregs and Tconvs T cell receptor repertoire, expressed as the % of unique TCR sequences
- HLA type and SNPs expressed as the occurrence events across patients
- (and 15 more...)
|
1300 |
All |
18 Years and older (Adult, Senior) |
NCT02466217 |
P141006
2015-A00558-41 |
TRANSIMMUNOM |
July 2015 |
July 2019 |
July 2021 |
June 9, 2015 |
December 13, 2016 |
|
- Rhumatologie - Hôpital Saint-Antoine
Paris, France - CIC Paris-Est, Hôpital PITIE SALPETRIERE
Paris, France
|
| 35 |
NCT02853084 |
Terminated |
HL2351 CAPS Phase II Study |
- Cryopyrin‑Associated Periodic Syndromes (CAPS)
|
|
Interventional |
Phase 2 |
- Handok Pharmaceuticals Co., Ltd.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Diary Symptom Sum Score (DSSS)
- Change in SAA, CRP, ESR levels
- Change in physician's global assessment of autoinflammatory using 100mm VAS score disease
- (and 6 more...)
|
8 |
All |
Child, Adult, Senior |
NCT02853084 |
HL_C201 |
|
October 2015 |
May 2017 |
January 2019 |
August 2, 2016 |
January 4, 2017 |
|
- Handok Inc.
Seoul, Korea, Republic of
|
| 36 |
NCT01213641 |
Completed |
Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients |
- Cryopyrin-associated Periodic Syndromes (CAPS)
- Familial Cold Autoinflam Syn (FCAS)
- Muckle-wells Syn (MWS)
- Neonatal Onset Multisystem Inflam Disease (NOMID)
|
|
Observational |
|
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To monitor and further explore the overall safey of canakinumab focusing in serious infections
- Long-term impact of Ilaris on disease progression (including systemic AA amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms, and sensorineural deafness)
- Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris
- (and 5 more...)
|
288 |
All |
Child, Adult, Senior |
NCT01213641 |
CACZ885D2401 |
B-Confident |
November 2009 |
December 2015 |
December 2015 |
October 4, 2010 |
March 28, 2016 |
|
- Little Rock Allergy and Asthma Clinic
Little Rock, Arizona, United States - Allergy Center at Brookstone
Columbus, Georgia, United States - Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States - (and 14 more...)
|
| 37 |
NCT01105507 |
Completed |
The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada |
- Cryopyrin Associated Periodic Syndrome
|
- Drug: canakinumab (company code: ACZ885D)
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety & tolerability of canakinumab by measuring the maintenance of response over time using the Investigators Clinical Assessment of Disease Activity scale and the evaluation of serum inflammation markers CRP (C-Reactive Protein), SAA (Serum Amyloid A.
- Change in long term maintenance of Health-Related Quality of Life and productivity measured from baseline to end of study.
- Treatment adherence with canakinumab for the duration of the study.
|
4 |
All |
4 Years and older (Child, Adult, Senior) |
NCT01105507 |
CACZ885DCA01 |
|
August 2010 |
May 12, 2012 |
May 12, 2012 |
April 16, 2010 |
March 21, 2017 |
|
- Alberta Children's Hospital, Department of Pediatrics
Calgary, Canada - Queen Elizabeth II Hospital
Halifax, Canada
|
| 38 |
NCT00770601 |
Terminated |
Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease |
|
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Novartis
|
Industry / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Inflammatory remission, CNS, peripheral blood
- Biomarkers
|
6 |
All |
2 Years to 25 Years (Child, Adult) |
NCT00770601 |
CACZ885D2201
09-AR-0006 |
|
January 2009 |
February 2011 |
|
October 10, 2008 |
May 4, 2012 |
|
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9
Bethesda, Maryland, United States
|
| 39 |
NCT01576367 |
Completed
Has Results |
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease |
- Cryopyrin-associated Periodic Syndromes
- Familial Cold Autoinflammatory Syndrome
- Muckle-Wells Syndrome
- Neonatal Onset Multisystem Inflammatory Disease
|
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
|
- The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Serological Inflammation Markers.
- Immunogenicity of Canakinumab (ACZ885). Number of Participants With Anti-canakinumab Antibodies
- Change From Baseline (Core Study Baseline) in C--Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations
- (and 2 more...)
|
17 |
All |
1 Year to 4 Years (Child) |
NCT01576367 |
CACZ885D2307E1
2011-005154-57 |
|
January 2012 |
October 2015 |
October 2015 |
April 12, 2012 |
August 3, 2016 |
August 3, 2016 |
- Novartis Investigative Site
Bruxelles, Belgium - Novartis Investigative Site
Laeken, Belgium - Novartis Investigative Site
Toronto, Ontario, Canada - (and 9 more...)
|
| 40 |
NCT01302860 |
Completed
Has Results |
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease |
- Cryopyrin-associated Periodic Syndromes
- Familial Cold Autoinflammatory Syndrome
- Muckle-Wells Syndrome
- Neonatal Onset Multisystem Inflammatory Disease
|
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Aged 4 Years or Younger With at Least One Complete Response at Week 56
- Percentage of Participants Aged 2 Years or Younger With at Least One Complete Response at Week 56
- Percentage of Participants With Defined Grades in Physician's Global Assessment Score at Week 56
- (and 6 more...)
|
17 |
All |
1 Month to 60 Months (Child) |
NCT01302860 |
CACZ885D2307
2009-016859-22 |
|
November 2010 |
November 2014 |
November 2014 |
February 24, 2011 |
March 29, 2017 |
August 18, 2015 |
- Novartis Investigative Site
Bruxelles, Belgium - Novartis Investigative Site
Laeken, Belgium - Novartis Investigative Site
Toronto, Ontario, Canada - (and 9 more...)
|
| 41 |
NCT01045772 |
Completed |
Safety and Tolerability of Rilonacept in Muckle-Wells Syndrome (MWS) or Schnitzler Syndrome (SchS) |
- Muckle-Wells Syndrome
- Schnitzler Syndrome
|
|
Interventional |
Phase 2 |
- Charite University, Berlin, Germany
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability parameters (including physical examination, PPD tuberculosis skin test, review of recent chest radiograph, electrocardiograms, routine safety laboratory assessments, clinical observations, vital signs, and adverse event reporting)
- Change of the mean MWAS (Muckle-Wells Activity Score) and SCHAS (Schnitzler Activity Score) from the 21-day baseline phase (day -21 to day 0) to the last 21 days of the first 4 weeks initial treatment phase (day 7 to 28) of the study.
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT01045772 |
ACCILTRA1
EudraCT Number: 2006-004290-97 |
ACCILTRA1 |
January 2009 |
September 2010 |
September 2010 |
January 11, 2010 |
May 31, 2012 |
|
- Charité University Hospital
Berlin, Germany
|
| 42 |
NCT00991146 |
Completed |
Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase |
- Cryopyrin-associated Periodic Syndromes
- Familial Cold Autoinflammatory Syndrome
- Muckle-Wells Syndrome
- Neonatal Onset Multisystem Inflammatory Disease
|
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants without a relapse
- Number of complete responder patients
- Clinical improvement (or resolution) with regards to: central nervous system (CNS) involvement, eye disease, hearing impairment, skin disease, joint disease, fever, and kidney function
- (and 3 more...)
|
19 |
All |
2 Years and older (Child, Adult, Senior) |
NCT00991146 |
CACZ885D2308 |
|
October 2009 |
February 2012 |
February 2012 |
October 7, 2009 |
February 23, 2017 |
|
- Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan - Novartis Investigative Site
Yokohama-city, Kanagawa, Japan - Novartis Investigative Site
Kyoto-city, Kyoto, Japan
|
| 43 |
NCT03410290 |
Recruiting |
Journey of Patients With Vasculitis From First Symptom to Diagnosis |
- Vasculitis
- Systemic Vasculitis
- Behcet's Disease
- (and 13 more...)
|
- Other: Online Questionnaire
|
Observational |
|
- University of Pennsylvania
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentages of patients with different types of vasculitis who report a delay in their disease diagnosis from initial symptoms of vasculitis to establishment of a diagnosis of vasculitis, stratified by disease type.
|
400 |
All |
Child, Adult, Senior |
NCT03410290 |
VCRC5538/V-PPRN4 |
|
January 11, 2018 |
January 31, 2019 |
February 28, 2019 |
January 25, 2018 |
January 25, 2018 |
|
- University of South Florida
Tampa, Florida, United States
|
| 44 |
NCT03371095 |
Not yet recruiting |
Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease |
- Behcet's Disease
- Vasculitis
|
- Drug: Infliximab
- Drug: Cyclophosphamide
|
Interventional |
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete clinical response
- Remission of CNS and/or cardiovascular involvement
- Percent meeting the target of ≤ 0.1 mg/day/kg of prednisone
- (and 18 more...)
|
52 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03371095 |
P160932J |
ITAC |
March 15, 2018 |
June 1, 2021 |
January 1, 2022 |
December 13, 2017 |
February 27, 2018 |
|
|
| 45 |
NCT03274648 |
Not yet recruiting |
Dietary Interventions and Butyrate Production in Behçet's Patients |
|
- Dietary Supplement: Oral butyrate
- Dietary Supplement: Vegetarian diet
- Dietary Supplement: Habitual diet
|
Interventional |
Not Applicable |
- Azienda Ospedaliero-Universitaria Careggi
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of gut microbiota composition
- Evaluation of butyrate production
- Complete blood count
- (and 13 more...)
|
30 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03274648 |
butyrate2017 |
|
October 2017 |
December 2017 |
January 2018 |
September 7, 2017 |
September 7, 2017 |
|
|
| 46 |
NCT03264391 |
Not yet recruiting |
Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography |
- Retinal Vasculitis
- Behcet Syndrome
|
|
Observational |
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Qualitative description of the retinal capillary plexus changes in the macular area
- Correlation between extent of macular vascular changes and visual acuity
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03264391 |
17100296 |
|
March 1, 2018 |
December 31, 2019 |
December 31, 2019 |
August 29, 2017 |
February 9, 2018 |
|
|
| 47 |
NCT03209219 |
Recruiting |
Interferon α2a Versus Cyclosporine for Refractory Behçet`s Disease Uveitis |
|
- Drug: Interferon Alfa-2A
- Drug: Cyclosporine Pill
|
Interventional |
Phase 3 |
- Peking Union Medical College Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- relapse rate
- severity of relapse using the BOS24
|
36 |
All |
18 Years to 65 Years (Adult) |
NCT03209219 |
Z171100001017217 |
|
June 30, 2017 |
January 2019 |
February 2019 |
July 6, 2017 |
July 6, 2017 |
|
- Peking Union Medical College
Beijing, Beijing, China
|
| 48 |
NCT03133767 |
Completed |
Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation |
- Fluid Loss
- Symptom Complex, Triple
- Emergencies
|
- Drug: Lactated Ringer Solution
- Drug: Normal Saline 0.9% Infusion Solution Bag
|
Interventional |
Phase 4 |
- Nicholas M Mohr
- University of Iowa
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Quality of Recovery-40 score at 24 hours
- Quality of Recovery-40 score after administration
- Filling ED prescriptions
- (and 2 more...)
|
157 |
All |
18 Years and older (Adult, Senior) |
NCT03133767 |
201701764 |
|
May 23, 2017 |
November 1, 2017 |
November 2, 2017 |
April 28, 2017 |
February 27, 2018 |
|
- University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
|
| 49 |
NCT00685373 |
Completed
Has Results |
Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease |
- Cryopyrin-Associated Periodic Syndromes
- Familial Cold Autoinflammatory Syndrome
- Muckle Wells Syndrome
- Neonatal Onset Multisystem Inflammatory Disease
|
- Drug: Canakinumab (ACZ885)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions
- The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers.
- Immunogenicity of Canakinumab (ACZ885)
- Pharmacokinetics
|
166 |
All |
3 Years and older (Child, Adult, Senior) |
NCT00685373 |
CACZ885D2306 |
|
May 2008 |
April 2010 |
April 2010 |
May 28, 2008 |
November 4, 2016 |
May 27, 2011 |
- Little Rock Allergy and Asthma Clinic
Little Rock, Arkansas, United States - UCSF School of Medicine
San Francisco, California, United States - Allergy Center at Brookstone
Columbus, Georgia, United States - (and 25 more...)
|
| 50 |
NCT02756650 |
Recruiting |
1 Year Canakinumab Treatment in Behcet's Disease Patients With Neurologic or Vascular Involvement |
|
- Drug: drug administration
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Resolution of attacks
- Prevention of attacks
- VAS
- Neuro behcet disease score
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT02756650 |
CACZ885NTR01 |
Behcet |
June 23, 2016 |
June 25, 2018 |
June 25, 2018 |
April 29, 2016 |
March 16, 2018 |
|
- Novartis Investigative Site
Istanbul, Turkey - Novartis Investigative Site
Mecidiyekoy/Istanbul, Turkey
|
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