Giant Cell Arteritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy After Remission-Induction Therapy With Tocilizumab and Glucocorticoids in Subjects With Giant Cell Arteritis
The standard treatment for Giant Cell arteritis (GCA) is Glucocorticoids(GC), even if GC-related adverse events are commonly occuring. Therefore, other practises for reducing relapses and cumulative GC-doses are needed. Currently, the Interleukin-6-inhibitor tocilizumab is used in combination with GC to achieve higher remission rates and lower cumulative GC-doses. The use of tocilizumab also has some disadvantages. One is the increased susceptibility to infections. On top of that, a long-term follow-up of the phase II study by Villiger et al. showed a 55% relapse-rate after discontinuation of intravenous tocilizumab after a median of five months. Studies have also shown that methotrexate(MTX) in combination with GC was able to prevent relapses and reduce cumulative GC doses. The aim of the study is to evaluate whether MTX is superior to placebo to prevent relapses in subjects with GCA after Remission-Induction Therapy with Glucocorticoids and Tocilizumab. Our hypothesis is that Methotrexate can maintain remission, once stable remission has been induced by GC and Tocilizumab and will prevent the occurrence of relapses.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03812302 -
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
|
Phase 2 | |
| Recruiting |
NCT02257866 -
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
|
||
| Recruiting |
NCT04888221 -
Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement
|
Phase 3 | |
| Recruiting |
NCT05380453 -
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
|
Phase 3 | |
| Recruiting |
NCT02333708 -
Study of Circulating Microparticles in Giant Cell Arteritis
|
||
| Completed |
NCT01450137 -
Tocilizumab for Patients With Giant Cell Arteritis
|
Phase 2 | |
| Completed |
NCT03827018 -
KPL-301 for Subjects With Giant Cell Arteritis
|
Phase 2 | |
| Active, not recruiting |
NCT04519580 -
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
|
||
| Recruiting |
NCT04239196 -
Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA
|
Phase 2 | |
| Completed |
NCT03202368 -
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
|
Phase 3 | |
| Not yet recruiting |
NCT06004154 -
Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)
|
||
| Not yet recruiting |
NCT02523625 -
Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
|
N/A | |
| Completed |
NCT03285945 -
FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment
|
N/A | |
| Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
| Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
| Terminated |
NCT02531633 -
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
|
Phase 3 | |
| Completed |
NCT03765424 -
Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
|
||
| Completed |
NCT03409913 -
Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA
|
N/A | |
| Completed |
NCT01910038 -
Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
|
Phase 2 | |
| Not yet recruiting |
NCT04012905 -
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
|
Phase 3 |