Clinical trials: Arteritis, Giant Cell
Polymyalgia Rheumatica
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult…
- Trial name
- REPLENISH (NCT05767034)
- Testing
- Secukinumab 300 mg, Secukinumab 150 mg
- Where
- 132 sites in United States, Argentina and 24 more
- Volunteers
- 381 people
- Sponsor
- Novartis Pharmaceuticals
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
Giant Cell Arteritis (GCA)
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)
This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)
- Trial name
- GCAptAIN (NCT04930094)
- Testing
- Secukinumab 300 mg, Secukinumab 150 mg
- Where
- 104 sites in United States, Argentina and 25 more
- Volunteers
- 354 people
- Sponsor
- Novartis Pharmaceuticals
Polymyalgia Rheumatica
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter…
- Trial name
- NCT03600818
- Testing
- Sarilumab SAR153191 (REGN88), Prednisone
- Where
- 84 sites in United States, Argentina and 15 more
- Volunteers
- 118 people
- Sponsor
- Sanofi
Polymyalgia Rheumatica
Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica
Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine with high affinity that may have therapeutic benefit in the treatment of polymyalgia rheumatica (PMR) by interrupting multiple pathogenic…
- Trial name
- NCT02899026
- Testing
- Sirukumab
- Sponsor
- GlaxoSmithKline
Giant Cell Arteritis
KPL-301 for Subjects With Giant Cell Arteritis
The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new…
- Trial name
- NCT03827018
- Testing
- mavrilimumab, prednisone
- Where
- 49 sites in United States, Australia and 13 more
- Volunteers
- 70 people
- Sponsor
- Kiniksa Pharmaceuticals, Ltd.
Giant Cell Arteritis
Assessment of Giant Cell Arteritis Medical Practices in France
The purpose of this study is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis.
- Trial name
- ARTEMIS (NCT03658889)
- Where
- France
- Volunteers
- 306 people
- Sponsor
- Chugai Pharma France
Giant Cell Arteritis (GCA)
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper…
- Trial name
- SELECT-GCA (NCT03725202)
- Testing
- Upadacitinib, Corticosteroid (CS)
- Where
- 172 sites in United States, Australia and 22 more
- Volunteers
- 429 people
- Sponsor
- AbbVie
Giant Cell Arteritis
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis…
- Trial name
- NCT02531633
- Testing
- Sirukumab, Prednisone
- Where
- 63 sites in United States, Australia and 11 more
- Volunteers
- 161 people
- Sponsor
- GlaxoSmithKline
Giant Cell Arteritis
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell…
- Trial name
- THEIA (NCT04633447)
- Testing
- Guselkumab
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 53 people
- Sponsor
- Janssen Research & Development, LLC
Polymyalgia Rheumatica
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older.
- Trial name
- AIM-PMR (NCT04972968)
- Testing
- ABBV-154, Glucocorticoid
- Where
- 117 sites in United States, Australia and 13 more
- Volunteers
- 181 people
- Sponsor
- AbbVie
Polymyalgia Rheumatica
A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
- Trial name
- NCT06281236
- Testing
- Prednisolone, SPI-62
- Where
- 5 sites in Germany
- Volunteers
- 1 people
- Sponsor
- Sparrow Pharmaceuticals
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
Polymyalgia Rheumatica
Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica (PROMISE)
The primary objective of the study is to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously every 2 weeks compared with placebo in participants with polymyalgia rheumatica (PMR).
- Trial name
- NCT07670546
- Testing
- Olokizumab
- Where
- 20 sites in Russia
- Volunteers
- 125 people
- Sponsor
- R-Pharm International, LLC
Giant Cell Arteritis
A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis
This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to 1 year (52 weeks) in patients with…
- Trial name
- TitAIN (NCT03765788)
- Testing
- Secukinumab 300 mg, s.c., Prednisolone
- Where
- 11 sites in Germany
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Polymyalgia Rheumatica
A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR
The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica.
- Trial name
- NCT01821040
- Testing
- Lodotra®, Prednisone IR (immediate release)
- Where
- United Kingdom
- Volunteers
- 62 people
- Sponsor
- Mundipharma Research Limited
Giant Cell Arteritis
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who subsequently have flare or persisting…
- Trial name
- NCT03202368
- Testing
- Tocilizumab
- Where
- 3 sites in France
- Volunteers
- 3 people
- Sponsor
- Hoffmann-La Roche
Giant Cell Arteritis, Polymyalgia Rheumatica
Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR
This study will examine how intravenous (i.v.) Secukinumab will be processed in the body (pharmacokinetics [PK]) and whether it will be safe and tolerable after multiple doses of i.v.
- Trial name
- NCT06130540
- Testing
- Secukinumab
- Where
- 19 sites in United States, Czechia and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Polymyalgia Rheumatica
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.
- Trial name
- NCT05436652
- Testing
- SPI-62, Prednisolone 10mg, Additional prednisolone
- Where
- 10 sites in Germany, Poland
- Volunteers
- 66 people
- Sponsor
- Sparrow Pharmaceuticals
Giant Cell Arteritis
A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)
To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.
- Trial name
- NCT03192969
- Testing
- Abatacept, Glucocorticoid Treatment
- Where
- 99 sites in United States, Australia and 19 more
- Sponsor
- Bristol-Myers Squibb