Early Rheumatoid Arthritis
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Product Code: Infliximab
Pharmaceutical Form: Powder for solution for infusion
Trade Name:
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women 18-80 years of age. 2. Fulfil 1987 ACR Criteria for RA . 3. Symptoms of >3 months and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, nursing, or planning pregnancy within 24 months after screening (ie, approximately 6 months following last study medications). 2. Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer. 3. Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline, thalidomide, infliximab, adalimumab etc.) 4. Prior treatment with any DMARD other than antimalarials. 5. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator. 6. Documented HIV infection. 7. Documented hepatitis- B or hepatitis-C. 8. Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section 4.3. 9. Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening. 10. Significant haematological or biochemical abnormality a. Haemoglobin ?8.5 g/dL b. WBC ?3.5 x 109/L c. Neutrophils ?1.5 x 109/L d. Platelets ?100 x 109/L e. ALT and AST ?3 times ULN for the laboratory conducting the test. f. Creatinine > 1.5 times normal 11. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis). 12. Concomitant congestive heart failure, including medically controlled asymptomatic patients. 13. Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening). 14. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). 15. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly. 16. Known recent substance abuse (drug or alcohol). 17. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period. 18. Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Section 4.3.2.1 19. Have a positive Mantoux test or Evidence of active TB infection, or recent close contact with an individual with active TB. 20. Previous oral, IM, IA or IV corticosteroids within 1 month. 21. Receiving treatment with anakinra. 22. Currently participating in another drug trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether use of Biologic Therapy (infliximab) as induction therapy in early rheumatoid arthritis results in less radiographic damage over 78 weeks compared to current best practice therapy: that is early introduction of DMARD in combination with steroid induction therapy and dose modification according to pre defined disease activity measures.; Secondary Objective: 1. The number of patients having a major clinical response. 2. The change in Sharpe van Der Heijde scores between baseline and 26 and 78 weeks. 3. The number of patients in clinical remission at 78 weeks. 4. The number of patients in clinical remission at 26 weeks, no longer on Infliximab / placebo infusions. 5. The number of patients in clinical remission at 78 weeks, no longer on Infliximab / placebo infusions. 6. The number of patients in clinical remission at 26 weeks. 7. RA Quality of Life questionnaire. 8. Health assessment questionnaire. 9. Immunogenetic studies to predict long term immune response. 10. Immune phenotype (flowcytometry) and assessment of immune effector and regulatory functions. 11. Assessment of serum and plasma markers to predict response to therapy and vascular function. ;Primary end point(s): Change in Sharpe van Der Heijde score at 78 weeks | — |
Countries
United Kingdom
Outcome results
None listed