Spondylarthropathies Clinical Trial
Official title:
Evaluation of Clinical Value of Standardized Protocol for Dose-reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy: Open-label, Controlled, Randomized, Multicenter Trial.
The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.
It has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04540432 -
Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment
|
N/A | |
| Completed |
NCT03173144 -
Chronic Inflammatory Disease, Lifestyle and Treatment Response
|
||
| Recruiting |
NCT01216631 -
Seronegative Oligoarthritis of the Knee Study (SOKS)
|
Phase 2 | |
| Completed |
NCT00133315 -
TNFalfa Blocking Treatment of Spondylarthropathies
|
Phase 4 | |
| Active, not recruiting |
NCT03456206 -
Chronic Inflammatory Disease, Lifestyle and Risk of Disease
|
||
| Completed |
NCT02436785 -
Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening?
|
N/A | |
| Completed |
NCT03358134 -
Mechanism of Action of Anti-IL17 Therapy in Peripheral Spondyloarthritis
|
Phase 3 | |
| Withdrawn |
NCT00298012 -
Methotrexate in the Treatment of Axial Spondyloarthritis
|
Phase 4 | |
| Recruiting |
NCT02809781 -
A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis
|
Phase 2/Phase 3 | |
| Completed |
NCT02098694 -
Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
|
N/A | |
| Completed |
NCT00591201 -
Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies
|
Phase 2/Phase 3 | |
| Completed |
NCT03190603 -
Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis
|
Phase 4 | |
| Active, not recruiting |
NCT06402396 -
Assessing Pain by the painDETECT Questionnaire (PDQ)
|
||
| Completed |
NCT04709354 -
Clinical and Dermoscopic Comparison of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriasis Patients' Nails
|