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Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and etanercept | Placebo Comparator | Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks |
|
| Niclosamide and etanercept | Experimental | Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity scale | Mean change of disease activity index from baseline using clinical disease activity index (CDAI). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity score | Mean change of disease activity index from baseline using simplified disease activity index (SDAI). | Day 2 |
| disease activity change scale | Mean change of disease activity index from baseline using disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed S Mahmood, MSc | Baghdad Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baghdad teaching Hospital | Baghdad | Iraq |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007785 | Lactose |
| D009534 | Niclosamide |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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1 patient group and 1 placebo group
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| Niclosamide | Drug | Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks |
|
| Etanercept | Drug | Etanercept 50mg weekly |
|
|
| Day 3 |
| The Change in disease activity scale | Mean change of disease activity index from baseline using health assessment quality of life (HAQDI). | 24 hours to 48 hours day |
| safety of niclosamide | Number of participants with treatment-related adverse events | Day 1 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000073893 |
| Sugars |
| D012458 | Salicylanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |