Clinical trials: FMF
Colchicine Resistant/Intolerant Familial Mediterranean Fever
Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
A study designed to evaluate the role of treatment with a biological agent - Canakinumab in pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or resistant for colchicine treatment.
- Trial name
- CONTROL FMF (NCT01148797)
- Testing
- Canakinumab
- Where
- 5 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Periodic Fevers Syndrome
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301…
- Trial name
- NCT02911857
- Testing
- Canakinumab (AIN457)
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever (FMF )
A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF
The purpose of this study is to evaluate the efficacy and safety of anakinra in Chinese patients with colchicine-resistand Familial Mediterranian Fever (FMF).
- Trial name
- NCT06666335
- Testing
- Anakinra
- Sponsor
- Swedish Orphan Biovitrum
Cryopyrin-Associated Periodic Syndromes
Kineret CAPS Post Authorisation Study
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies…
- Trial name
- NCT02326376
- Testing
- anakinra (Kineret)
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Swedish Orphan Biovitrum
Cryopyrin-Associated Periodic Syndromes (CAPS)
HL2351 CAPS Phase II Study
This is an open label, single arm trial to evaluate the efficacy, safety, and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).
- Trial name
- NCT02853084
- Testing
- HL2351
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Handok Inc.
Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
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
This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β [anti-IL-1β] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102…
- Conditions
- Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT00685373
- Testing
- Canakinumab (ACZ885)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 166 people
- Sponsor
- Novartis
NOMID, CINCA Syndrome
Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease
This study will examine whether a medicine called canakinumab is safe and effective for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic, cutaneous…
- Trial name
- NCT00770601
- Testing
- Canakinumab
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS)
Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients
The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.
- Conditions
- Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS), Muckle-wells Syn (MWS), Neonatal Onset Multisystem Inflam Disease (NOMID)
- Trial name
- B-Confident (NCT01213641)
- Where
- 17 sites in United States, Austria and 3 more
- Volunteers
- 288 people
- Sponsor
- Novartis Pharmaceuticals
Cryopyrin Associated Periodic Syndrome
The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
This study will assess the safety, tolerability and efficacy of canakinumab treatment in Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.
- Trial name
- NCT01105507
- Testing
- canakinumab (company code: ACZ885D)
- Where
- 2 sites in Canada
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Behcet's Disease
Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease. 1.
- Trial name
- NCT01960790
- Volunteers
- 473 people
- Sponsor
- AbbVie
Mevalonate Kinase Deficiency
Canakinumab in Patients With Active Hyper-IgD Syndrome
This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.
- Trial name
- NCT01303380
- Testing
- Canakinumab
- Where
- 3 sites in Spain
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
NALP3 Mutation
Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms
This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are…
- Trial name
- NCT00487708
- Testing
- canakinumab
- Where
- 10 sites in France, Germany and 3 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever, FMF
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
The primary objective is to evaluate the main pharmacokinetic (PK) parameters, efficacy, and safety of goflikicept (GFC) in children and adolescents with colchicine-resistant or colchicine-intolerant familial Mediterranean fever…
- Trial name
- NCT07880886
- Testing
- RPH-104
- Where
- 3 sites in Russia
- Volunteers
- 18 people
- Sponsor
- R-Pharm
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
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
This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS patients that completed the CACZ885D2307 study
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT01576367
- Testing
- ACZ885
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS)
Ilaris NIS in Korea
This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes…
- Conditions
- Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS)
- Trial name
- REASSURE (NCT06838143)
- Testing
- Ilaris
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Behçet Disease
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD)…
- Trial name
- BEAN (NCT04528082)
- Testing
- Apremilast
- Where
- 27 sites in France, Greece and 6 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Familial Mediterranean Fever
Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.
- Trial name
- NCT01088880
- Testing
- Canakinumab
- Where
- Turkey (Türkiye)
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
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
To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset…
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT00991146
- Testing
- canakinumab
- Where
- 3 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever
A Study to Describe a Group of Spanish Patients With FMF and to Identify Suboptimally Treated Patients With Minimal Disease Activity and Its Impact on Quality of Life
A retrospective, non-interventional, single-center study conducted in Spain, based on the collection of data from the medical histories of patients with Familial Mediterranean fever (FMF) diagnosed during childhood from January…
- Trial name
- NCT06923124
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger patients by inexact dosing through breaking or…
- Trial name
- NCT01075906
- Testing
- colchicine sprinkle capsules
- Where
- 10 sites in United States, Armenia and 2 more
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.