Rheumatoid Arthritis (RA)
Conditions
Keywords
Niclosamide, Rheumatoid arthritis, diseases activity, Efficacy, Safety
Brief summary
Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis
Detailed description
In this randomized double blind placebo-controlled pilot study (Phase I study) we will assess the efficacy and safety of adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis.
Interventions
DRUGPlacebo
Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
DRUGNiclosamide
Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
DRUGEtanercept
Etanercept 50mg weekly
Sponsors
Faiq Gorial
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
1 patient group and 1 placebo group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with RA, as defined by the American College of Rheumatology (ACR) 1987 revised criteria or ACR/EULAR 2010, * Severly Active RA by calculating either DAS28 or SDAI or CDAI. * Patient selected are those who started etanercept for less than 3months and still active.
Exclusion criteria
* Patients on nonsteroidal anti-inflammatory drugs (NSAID) 2 days before entry into this study. or methotrexate (MTX).. * Patients with hypersensitivity or severe adverse effects to niclosamide . * Renal impairment. * Hepatic impairment. * Pregnancy or a desire to become pregnant. * Breast feeding. * Patients with Juvenile RA \[16 years old or younger\]. * Patients using other conventional disease modifying antirheumatic drugs (DMARDs). * Patients on steroid. * Patients with coexistence other connective tissue diseases or hypothyroid disease. * Patient with mild or inactive RA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in disease activity scale | Day 1 | Mean change of disease activity index from baseline using clinical disease activity index (CDAI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of niclosamide | Day 1 | Number of participants with treatment-related adverse events |
| Change in disease activity score | Day 2 | Mean change of disease activity index from baseline using simplified disease activity index (SDAI). |
| disease activity change scale | Day 3 | Mean change of disease activity index from baseline using disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). |
| The Change in disease activity scale | 24 hours to 48 hours day | Mean change of disease activity index from baseline using health assessment quality of life (HAQDI). |
Countries
Iraq
Outcome results
None listed