Induction of remission in RA patients at low disease activity by additional Infliximab-therapy
- Conditions
- Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion.
- Registration Number
- EUCTR2005-004530-40-AT
- Lead Sponsor
- AESCA Pharma Ges.m.b.H
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
•Age: > 35 years and < 65 years.
•Diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year
(max. 10 years) prior to start of therapy.
•Patients have active disease: DAS 28 between 2,8 and 3,5
•Changes in DAS 28 score <0.6 during the last 6 weeks before inclusion.
•RA basic therapy must be stable and according to standard criteria for at least 3 months.
•The screening laboratory test results must meet the following criteria:
Hemoglobin > 10.0 g/dL, WBC> 3.5 x 109/L;Neutrophils > 1.5 x 109/L
Platelets> 100 x 109/L ,SGOT (AST), SGPT (ALT) and alkaline phosphatase, total bilirubin and serum creatinine levels must be within < 2 times the UNL
Prothrombin time INR < 1.5
•Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should be willing to continue such precautions for 6 months after receiving the last infusion.
•Patient must have at least 1 swollen joint.
•Patient must have evidence of erosive disease by x-ray at baseline.
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) no
F.1.3.1 Number of subjects for this age range
•Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion).
•Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
•History of any other therapeutic agent targeted at reducing TNF
•History of previous administration of Infliximab.
•History of receiving human/murine recombinant products or known allergy to murine products.
•Serious infections (such as hepatitis, 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.
•Have active TB or have evidence of latent TB
•HBs antigen positive, HCV antibody positive, documented HIV infection
•Patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobac-terium infection, etc, within the previous 6 months.
•Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, psychiatric, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
•Concomitant congestive heart failure = NYHA II
•Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
•Fibromyalgia
•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).
•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.
•Known recent substance abuse (drug or alcohol).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the rate of remissions according to DAS 28 (< 2,6) at the end of treatment (after 38 weeks) ;Secondary Objective: •To compare the change of DAS 28 between start of Infliximab treatment and end of treatment (after 38 weeks)<br>•To evaluate quality of life<br>•To compare the proportions achieving EULAR (ACR) response<br>To compare the post treatment DAS 28 at week 62 and the change of DAS 28 at week 14 and the end of treatment (week 38) <br>•To evaluate disease progression via X-Ray<br>•To evaluate the influence of IL-6 receptor, IL-1 receptor antagonist, sol. TNF receptor type I/II, soluble ICAM-1 and CRP on response and disease progression<br>•To assess the SDAI<br>;Primary end point(s): •To assess the rate of remissions according to DAS 28 (< 2,6) at the end of treatment (after 38 weeks) <br>
- Secondary Outcome Measures
Name Time Method