Health Condition 1: null- Active Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Infliximab code named as R TPR 015 & Methotrexate: Infliximab:
Dosage: 3 mg/kg given as an intravenous infusion at Week 0, followed with similar doses at Weeks 2, 6, 14, 22, 30, 38 and
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female aged 18 to 65 inclusive 2 Diagnosis of RA according to the criteria based on the revised 2010 American College of Rheumatology (ACR)or EULAR RA Classification criteria The disease should have been diagnosed at least 2 years prior to screening 3 Patients must have ACR or EULAR diagnostic criteria score More than equal to 6 4 Patients must have active disease as defined by a More than equal to 6 swollen joints b More than equal to 6 tender joints and the following i ESR More than equal to 28 mm per h ii CRP More than equal to 10 mg per L 5 Patients must have been on treatment with methotrexate (10 to 20 mg per week) taken orally for at least 3 months with no break(s) in treatment of more than 2 weeks total during this period and on stable dose between 10 and 20 mg per week for at least 4 weeks prior to screening and for the entire duration of the study 6 Patients using oral corticosteroids must have been on a stable dose of Less than equal to 5 mg per day Prednisolone or equivalent for at least 4 weeks prior to screening If currently not using corticosteroids the subject must have not received corticosteroids for at least 4 weeks prior to screening 7 If using NSAIDs (excludes rofecoxib [Vioxxï??]) patients should have been on a stable dose for at least 4 weeks prior to screening If currently not using NSAIDs the patient must have been off for at least 4 weeks prior to screening 8 The screening laboratory tests must meet the following criteria a Hemoglobin NLT 5.3 mmol per L (NLT 8.0 g per dL) providing a low hemoglobin level is not due to nutritional deficiencies or due to diseases other than chronic RA b WBC NLT 3500 millions per L c Neutrophils NLT 1500 millions per L d Platelets NLT 100000 millions per L e Serum transaminase Less than equal to 2 times the upper limit of normal f Alkaline phosphatase levels Less than equal to 2 times the upper limit of normal g Serum creatinine Less than equal to 150 µmol per L (Less than equal to 1.7 mg per dL) 9 Patient must be able to adhere to the study visit schedule and other protocol requirements 10 Patient must be capable of giving informed consent and the consent must have been obtained prior to any study procedures 11 Patients must have the ability to understand and comply with the instructions and be able to complete study related forms and questionnaires 12 Men and women of childbearing potential must be using adequate birth control measures and should continue such precautions for 6 months after receiving the last infusion 13 Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential
Exclusion criteria
Exclusion criteria: 1 Pregnant women nursing mothers or a planned pregnancy within 1and half years of randomization 2 Patients who are incapacitated largely or wholly bedridden or confined to a wheelchair and who have little or no ability for self-care 3 Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the Infliximab therapy eg Lyme disease or a rheumatic disease other than RA 4 History within one year prior to randomization of illicit drug use 5 History of alcohol abuse within 5 years of screening 6 Prior use of infliximab adalimumab abatacept certolizumab golimumab tocilizumab rituximab etanercept or anakinra (or any biological treatment for the treatment of RA) 7 Prior use of Disease-modifying antirheumatic drugs (DMARDs) other than methotrexate including hydroxychloroquine chloroquine or sulfasalazine within 4 weeks prior to Screening Patients who discontinued leflunomide and have had successful chelation with 8 g of cholestyramine (3 times daily) for 11 days must wait 4 weeks prior to Screening Patients who discontinued leflunomide and did not have cholestyramine washout must wait 12 weeks after last dose of leflunomide before randomization 8 Patients must not be on herbal homeopathic and ayurvedic medicines including massage or manipulation therapies for at least 1 month prior to randomization 9 Patients who have a current or past history of chronic infection with hepatitis B hepatitis C or infection with human immunodeficiency virus 1 or 2 or who have a positive result to the screening test for those infections 10 History or presence of any form of cancer within the 10 years prior to randomization with the exception of excised basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis 11 Current signs or symptoms of severe progressive or uncontrolled renal hepatic hematologic gastrointestinal endocrine pulmonary cardiac neurologic or cerebral disease 12 History of congestive heart failure (New York Heart Association [NYHA] class III or IV) or unstable angina 13 History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck infraclavicular epitrochlear or periaortic areas) or splenomegaly 14 Presence of psoriatic arthritis vasculitis interstitial lung disease severe extra articular manifestations or other auto-immune diseases 15 Major surgery (including joint surgery) within 12 weeks prior to randomization 16 History of serious infection which caused hospitalization within 6 months prior to randomization or other severe or chronic infection (such as sepsis abscess or opportunistic infections invasive fungal infection such as histoplasmosis or who have a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment 17 Infection requiring parenteral antibiotic treatment within 4 weeks of randomization <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the proportion of patients achieving clinical response according to the ACR20 criteriaTimepoint: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR 20Timepoint: Weeks 30 38 and 54;ACR 50Timepoint: Weeks 16 30 38 and 54;ACR 70Timepoint: Weeks 16 30 38 and 54;Assess immunogenicity of R-TPR-015 (1422015)Timepoint: Week 16 and 30;Change from baseline in the Quality of Life Assessment QuestionnaireTimepoint: Weeks 16 30 and 54;Incidence and severity of adverse events and clinical laboratory abnormalitiesTimepoint: Week 16 30 38 and 54;Mean decrease of DAS28 comparison with BaselineTimepoint: Weeks 16 30 38 and 54;Number of patients requiring salvage treatmentTimepoint: Weeks 30 and 54 | — |
Countries
India
Contacts
Public ContactMs Jamila Joseph
Reliance Life Sciences Pvt. Ltd.
Outcome results
None listed