To determine the safety and efficacy of Etanercept for injection 25 mg in patients with moderate to severe active rheumatoid arthritis.
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2009/091/000399
- Lead Sponsor
- Cipla Ltd R and D Centre LBS Marg Vikhroli W Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Written informed consent after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. 2. Male or female patients aged more than 18 to 70 years. 3. Definite diagnosis made in line with American College of Rheumatology (ACR) 1987 revised criteria. Diagnosis of rheumatoid arthritis meeting at least four of seven of the following criteria:
A.Morning stiffness duration >1 hr lasting >6 weeks.
B.Soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician lasting > 6 weeks.
C.Arthritis of hand joints; swelling of the proximal interphalangeal, metacarpophalangeal, or wrist joints lasting > 6 weeks.
D.Symmetric swelling (arthritis) at least one area, lasting > 6 weeks.
E.Rheumatoid nodules; as observed by a physician.
F.Serum rheumatoid factor; as assessed by a method positive.
G.Radiographic changes; erosions and/or periarticular osteopenia in hand and/or wrist joints.
4.Patients having inadequate response to at least one but not more than four disease-modifying antirheumatic drugs (DMARDs) e.g. hydroxychloroquine, Sulfasalazine, oral or injectable gold, D-penicillamine, including methotrexate.
5.Patients willing to continue the appropriate dose of Methotrexate and discontinuing other DMARDs for rest of the study duration if the patient is found maintaining on DMARDs during screening.
6.ESR (Westergren) >=28mm/h
7.Stabilizing the dosage at least for 4 weeks before the enrolment if the patient was found taking oral NSAIDs during screening.
8.Stabilizing the dosage of oral glucocorticosteroids at least for 4 weeks (<=10 mg/day equivalent to prednisone) if the patient was found taking oral glucocorticosteroids during the screening.
9.Able to self administer the injection or with the help of an assistant and store the investigational medicinal product (IMP) at 2-80C.
1.Patients with history or presence of cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, metabolic, dermatologic, neurological, psychiatric or other immunologic disease which is considered as significant at the discretion of Principal Investigator.
2.Patients currently suffering from acute or chronic infections or history of recurring and chronic infections or active and inactive/latent tuberculosis (i.e. Mantoux Tuberculosis Skin test; Induration of >=10 mm) or sepsis or risk of sepsis.
3.Patients who have:
•Haemoglobin < 8.5 g/dl
•Clinically significant out of range values of AST(SGOT), ALT(SGPT) (i.e. more than 1.5 times the upper limit of normal values)
•Any other clinically significant abnormal lab values at the discretion of investigator.
4.Malignancies or susceptible population of family history.
5.Patients at risk of Hepatitis B virus.
6.Patients who are on live vaccinations.
7.Patients who have a previous history of blood dyscrasias.
8.Patients previously treatment with Etanercept or other bio-tech products within 6 months from screening.
9.Patients who have received Leflunomide treatment within 4 weeks of screening.
10.Patients who have received glucocorticosteroids treatment in joint cavities within 4 weeks of screening.
11.Known hypersensitivity to Etanercept or any of the components of study medication.
12.Patients with history of alcohol, drug or chemical abuse which is considered as significant at the discretion of Principal Investigator.
13.Pregnancy, lactation period or females of child-bearing age unwilling to take adequate contraceptive precautions.
14.Treatment with any other investigational drug in a clinical trial in the last 3 months before initiation of this trial.
15.Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study.
16.In the investigatorâ??s opinion, patients unlikely to comply with study procedures.
17.Patients previously enrolled into this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method