NCT03649061Befejeződött4. fázis
RCT part: COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA. LTE part: Long Term observational follow-up on patients started in CareRA2020 RCT (COBRA Slim with or without fast access to TNF blockade for remission induction in RA).
RCT part: CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. LTE part: CareRA2020 LTE: a 3 year longitudinal observational, multicenter, follow-up of early RA patients after participation in the CareRA2020 RCT.
Forrás: EU CTIS (euclinicaltrials.eu) · Utoljára frissítve: 2024. febr. 1.
Rövid összefoglaló (regiszter, angolul)
RCT part: The primary objective is to compare in an early RA population with insufficient response (not achieving DAS28CRP≤3.2 within 32 weeks or DAS28CRP<2.6 at week 32) to COBRA-Slim remission induction, the long term effectiveness of accelerated access to a six-month course of anti-TNF therapy (etanercept) within a time window from week 8 up to week 32, versus further treatment adaptation according to the standard COBRA-Slim strategy. For this purpose, the area under the DAS28CRP curve from BL until w104 will be assessed. This outcome parameter is considered to be clinically very relevant, since it reflects the overall evolution in disease burden over the first 2 years of treatment, taking into account the speed and stability of the response and the need for consecutive treatment adaptations. LTE part: To evaluate the clinical disease course and safety for three years following participation of RA patients in the CareRA2020 RCT depending on the original treatment allocation.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 442 (tényleges)
- Első benyújtás
- 2024. jan. 5.
- Kezdés
- 2018. máj. 15.
- Fő szponzor
- UZ Leuven
- Betegségek
- Rheumatoid arthritis
- NCT-szám
- NCT03649061
- EU CT-szám
- 2023-510189-28-00
- EudraCT-szám
- 2017-004054-41
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Bevont résztvevők: 442
- 21 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) EU CTIS (euclinicaltrials.eu) regisztermezőiből összeállítva. A vizsgálatot írja le, nem a te helyzetedet.
Ki nem vehet részt
Szó szerint a(z) EU CTIS (euclinicaltrials.eu) forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Previous treatment with: MTX or leflunomide; cyclophosphamide, azathioprine or cyclosporine; sulfasalazine (SSZ) for more than 3 weeks; hydroxychloroquine for more than 6 weeks; oral GC for more than 4 weeks within 4 months before screening; oral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline; oral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline; intra-articular, intravenous or intramuscular GC within 4 weeks before BL; an investigational drug for the treatment/prevention of RA
- Alcohol or drug abuse
Más betegség
- History of chronic heart failure
- History of severe infections or chronic infection
- History of malignant neoplasm within 5 years
- Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
Egyéb
- Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)
- Active TB
- Latent TB unless adequate prophylactic treatment is given according to local guidelines
- No access to the Belgian Health Insurance system
- For the LTE part: No exclusion criteria are applicable.
- Contra indications for GC
- Contra indications for TNF blocking agents
- Contra indications for MTX or leflunomide
- Psoriatic Arthritis
Kiket keres a vizsgálat
- Diagnosis of RA as defined by the ACR/EULAR2010 criteria for early RA
- Early RA defined by a diagnosis made ≤ 1 year ago.
- Use a reliable method of contraception for women of childbearing potential to be evaluated as in daily clinical practice
- Able and willing to give written informed consent and to participate in the study
- Understanding and able to write Dutch or French
- for the LTE part: Patients participated in the CareRA2020 RCT, who completed w104 of the RCT and are able and willing to give written informed consent can participate in this long term observational follow-up.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (21)
Helyszínek a regiszter sorrendjében. A betegség oldalán választott várossal távolság szerint rendeződnek.
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.