Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA

Phase 1

• Conditions: Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody)

• Registration Number: EUCTR2006-001428-38-GB
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-29
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age over 18 years
2. Synovial swelling of at least 1 joint confirmed by clinical assessment
3. Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of < 12 weeks.
4. Seropositivity for RF and anti-CCP Ab
5. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study.
6. Female subjects of childbearing potential must test negative for pregnancy
In addition,
1. All subjects must have provided written informed consent prior to admission to the study.
2. The subject must be able to understand and comply with the protocol requirements, instructions and restrictions.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous history of inflammatory arthritis.
2. Previous use of DMARDs or anti-TNF-agents.
3. Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders).
4. Clinical evidence of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to study entry.
5. Administration, or expected administration, of any live virus or bacterial vaccination within 3 months before the first administration of study agent, or during the trial.
6. A history of an infected joint prosthesis, or administration of antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
7. Known infection with HIV, hepatitis B, or hepatitis C.
8. A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent.
9. Serious and uncontrolled co-existing disease that in the opinion of the investigator preclude the use of TNF-blocking medication, methotrexate or depomedrone (including pulmonary disease on chest radiograph, congestive cardiac failure (NYHA grade 3 or 4), history of demyelinating disease such as multiple sclerosis or optic neuritis).
10. Bleeding disorder of the use of anti-coagulants
11. Any known malignancy or a history of malignancy within the previous 5 years (with the exception of a basal cell carcinoma that has been treated with no evidence of recurrence).
12. Any other contraindication to etanercept, methotrexate or parenteral depomedrone.
13. Patients will also be excluded with the following laboratory results: haemoglobin <8.5 gm/dl, total white cell count <3.5 x 109/litre, serum transaminase value more than twice the upper limit of normal, and serum creatinine >150 micromoles/litre.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified