Clinical trials: Interleukin 1-beta
Systemic Juvenile Idiopathic Arthritis
Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare.
- Trial name
- β-SPECIFIC 1 (NCT00886769)
- Testing
- Canakinumab
- Where
- 91 sites in United States, Argentina and 20 more
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Type 2 Diabetes Mellitus
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose…
- Trial name
- NCT00605475
- Testing
- Canakinumab, Metformin
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 231 people
- Sponsor
- Novartis
Polymyalgia Rheumatica, Inflammatory Diseases
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety…
- Trial name
- NCT01364389
- Testing
- AIN457, ACZ885, Prednisone
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerosis
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated…
- Trial name
- CANTOS (NCT01327846)
- Testing
- Canakinumab, Standard of care
- Where
- 1,131 sites in United States, Argentina and 38 more
- Volunteers
- 10,066 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.
- Trial name
- NCT02667639
- Testing
- RPH-104, Sodium chloride Sterile Injection 0.9% w/v
- Where
- Turkey (Türkiye)
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- R-Pharm
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
Systemic Juvenile Idiopathic Arthritis
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with…
- Trial name
- β-SPECIFIC 3 (NCT00891046)
- Testing
- Canakinumab
- Where
- 73 sites in United States, Argentina and 19 more
- Volunteers
- 270 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis
The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients…
- Trial name
- NCT00424346
- Testing
- Canakinumab
- Where
- 17 sites in United States, Austria and 4 more
- Volunteers
- 274 people
- Sponsor
- Novartis
Rheumatoid Arthritis
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
- Trial name
- NCT00487825
- Testing
- Canakinumab (investigational), Methotrexate (MTX)
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 78 people
- Sponsor
- Novartis
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 assess the safety, efficacy and tolerability of ACZ885 in patients aged 4 years and younger with cryopyrin associated periodic syndromes (CAPS)
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT01302860
- Testing
- ACZ885
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Abdominal Aortic Aneurysm (AAA)
ACZ885 for the Treatment of Abdominal Aortic Aneurysm
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA).
- Trial name
- AAA (NCT02007252)
- Testing
- ACZ885
- Where
- 9 sites in United States, Denmark and 3 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density…
- Trial name
- NCT00554606
- Testing
- Canakinumab
- Where
- 51 sites in United States, Belgium and 7 more
- Volunteers
- 115 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
Systemic Juvenile Idiopathic Arthritis With Active Flare
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.
- Trial name
- β-SPECIFIC 2 (NCT00889863)
- Testing
- canakinumab
- Where
- 73 sites in United States, Argentina and 17 more
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
Arthritis, Gouty
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
- Trial name
- NCT00663169
- Testing
- canakinumab, dexamethasone
- Where
- 4 sites in United States, Switzerland and 1 more
- Volunteers
- 6 people
- Sponsor
- Novartis
Pulmonary Sarcoidosis
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis
The purpose of this study is to assess if ACZ885 will improve lung function in association with reduction of tissue inflammation in patients with chronic sarcoidosis.
- Trial name
- NCT02888080
- Testing
- ACZ885
- Where
- 8 sites in United States, Germany and 1 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis
This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile…
- Trial name
- NCT00504595
- Testing
- ACZ885 (investigational)
- Where
- 4 sites in Russia, Spain and 2 more
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Novartis
Muckle Wells Syndrome
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells…
- Trial name
- REMITTER (NCT00465985)
- Testing
- ACZ885
- Where
- 12 sites in United States, France and 4 more
- Volunteers
- 35 people
- Sponsor
- Novartis