Rheumatoid Arthritis Clinical Trial
— ROCOfficial title:
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
| Verified date | August 2021 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | August 12, 2013 |
| Est. primary completion date | August 12, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Active and erosive rheumatoid arthritis with a DAS28 equal or greater than 3.2 - Inadequate response to a 1st anti-TNF - Stable or no treatment with any DMARDs, or oral corticosteroids (< or = to 10 mg/day of prednisone equivalent)during the preceding month Exclusion Criteria: - Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab - Pregnancy - Age < 18 years - Impossibility to give informed consent - Impossibility to be followed for 12 months |
| Country | Name | City | State |
|---|---|---|---|
| France | Polyclinique de Picardie | Amiens | |
| France | Centre Hospitalier de Belfort-Montbéliard | Belfort | |
| France | CHU de Besançon - Hôpital Jean Minjoz | Besançon | |
| France | Hôpital Jean Verdier | Bondy | |
| France | CHU Bordeaux - Hôpital Pellegrin | Bordeaux | |
| France | Hôpital Ambroise Paré | Boulogne - Billancourt | |
| France | CHU de la Cavale Blanche | Brest | |
| France | CHU de Caen | Caen | |
| France | Centre Hospitalier Jean Rougié | Cahors | |
| France | Centre Hospitalier de Cannes | Cannes | |
| France | CHU Gabriel Montpied | Clermont-Ferrand | |
| France | Hôpitaux Civils de Colmar | Colmar | |
| France | CHU de Grenoble - Hôpital Sud | Grenoble | |
| France | Hôpital Bicêtre | Kremlin Bicetre | |
| France | Centre Hospitalier Départemental Les Oudairies | La Roche Sur Yon | |
| France | Groupe Hospitalier du Havre - Hôpital J.Monod | Le Havre | |
| France | Centre Hospitalier du Mans | Le Mans | |
| France | Polyclinique de Riaumont | Lievin | |
| France | CHRU Lille - Hôpital Salengro | Lille | |
| France | CHU de Limoges | Limoges | |
| France | CH Saint Philibert | Lomme | |
| France | Hôpital de la Conception | Marseille | |
| France | CHU de Montpellier - Hôpital Lapeyronie | Montpellier | |
| France | CHU Montpellier, Hôpital Lapeyronie | Montpellier | |
| France | Centre Hospitalier de Mulhouse - Hôpital Emile Muller | Mulhouse | |
| France | CHU de Nantes - Hôtel Dieu | Nantes | |
| France | CHU de Nice - Hôpital de l'Archet 1 | Nice | |
| France | Centre Hospitalier Régional d'Orléans, Hôpital de la Source | Orleans | |
| France | CHU Chenevier - Mondor | Paris | |
| France | Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon | Paris | |
| France | Hôpital Bichat | Paris | |
| France | Hôpital de la Pitié Salpétrière | Paris | |
| France | Hôpital Lariboisière | Paris | |
| France | Hôpital Saint-Antoine | Paris | |
| France | CHU de Poitiers - Hôpital de la Milétrie | Poitiers | |
| France | Centre Hospitalier René Dubos | Pontoise | |
| France | CHU de Reims - Hôpital Maison Blanche | Reims | |
| France | CHU de Rennes - Hôpital Sud | Rennes | |
| France | CHU de Rouen - Hôpital Bois Guillaume | Rouen | |
| France | CHU de Saint-Etienne | Saint-Etienne | |
| France | Hôpital de Hautepierre | Strasbourg | |
| France | CHU de Toulouse - Hôpital Purpan | Toulouse | |
| France | CHU de Nancy - Hôpital Brabois | Vandoeuvre-les-nancy | |
| Monaco | Centre Hospitalier - Princesse Grâce de Monaco | Monaco |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France, Monaco,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of EULAR responders | 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
| Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
| Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
| Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
| Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
| Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
| Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
| Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
| Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
| Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
| Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
| Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
| Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
| Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
| Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
| Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |