Juvenile Idiopathic Arthritis
Conditions
Keywords
JIA
Brief summary
This open labelled randomized controlled trial will be carried out at the University of Child Health and the Children's Hospital, Lahore consisting of 6 months . In total 60 patients (30 in each group) fulfilling the inclusion criteria will be selected and enrolled in this study. Patients will be divided into two groups; Group A (Injection Etanercept+ Tab methotrexate) and Group B (Injection Etanercept+ Tab methotrexate). Data will be collected at baseline, 1,3 and 6 months. Data will be collected and recorded
Detailed description
Juvenile Idiopathic Arthritis (JIA) is the primary form of inflammatory arthritis observed in children. JIA is characterized by inflammation of the synovial tissue, which is present in joints, around tendons. The treatment approach for JIA depends on the specific subtype and severity of the disease. It involves the use of various medications, including non-steroidal anti-inflammatory drugs (NSAIDs), oral and intra-articular corticosteroids, as well as both biologic and nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). This open labelled randomized controlled trial will be carried out at the University of Child Health and the Children's Hospital, Lahore consisting of 6 months after approval. In total 60 patients (30 in each group) fulfilling the inclusion criteria will be selected and enrolled in this study. Patients will be divided into two groups; Group A (Injection Etanercept+ Tab methotrexate) and Group B (Tab methotrexate Monotherapy). Data will be collected at baseline, 1,3 and 6 months. Data will be collected and recorded on a performa. Data will be analyzed through SPSS version 26. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. chi-square test will be used to estimate the association between qualitative variables. A p-value\<0.05 will be significant. The primary goal of this study is to reduce the duration of active arthritis, improve the quality of life for both patients and their parents, and minimize the risk of irreversible osteoarthritic changes
Interventions
DRUGInjection, Etanercept, 25 Mg (Code May Be Used for Medicare When Drug Administered Under the Direct Supervision of A Physician, Not for Use When Drug is Self Administered)
Injection Etanercept is biological TNF Inhibitor.
Sponsors
University of Child Health Sciences and Children's Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open label study, No masking both the participants and the investigators, including care providers and outcome assessors, are aware of the treatment assignments.
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
Polyarticular JIA patients aged 2-16years Male or female patients Newly diagnosed patients
Exclusion criteria
Other type of JIA including systemic-onset JIA, psoriatic arthritis, enthesitis-related arthritis, and oligoarticular arthritis Chronic or acute infection or severe infection episodes that required hospitalization or intravenous administration of antibiotics 30 days prior to study initiation A previous history of malignancy Active tuberculosis or any opportunistic infection, including herpes zoster Hepatitis B Positive patients A history of any chronic disease (except for JIA) that could influence the effectiveness or safety of the investigational medicinal product in investigator's opinion \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA | 24 weeks | Proportion of patients achieving minimal/Low disease activity based on JDAS-10 between 0.8 t0 3.9 in Polyarticular Juvenile Idiopathic Arthritis. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORFaisal Haneef
University of Child Health Sciences Lahore.
Outcome results
None listed