Psoriatic Arthritis Clinical Trial
Official title:
Metformin: A Valid Add-On Drug in the Treatment of Psoriatic Arthritis-Randomized Controlled Trial
Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic inflammation and proinflammatory cytokines. Clinical observations and experimental results argue for an anti-inflammatory and immunosuppressant property of MET.
The chronic inflammatory nature of psoriasis and PsA predisposes patients to cardiovascular
diseases and metabolic syndrome (MetS). MetS is associated with systemic inflammation and
proinflammatory cytokines.Clinical observations and experimental results argue for an
anti-inflammatory and immunosuppressant property of MET.
A randomized placebo-controlled trial was conducted to evaluate the efficacy and safety of
metformin as add-on therapy to MTX compared to MTX after 24 weeks in patients with PsA.
The study randomized 56 patients with a diagnosis of PsA . Patients with a history of a
cardiovascular event and diabetics were excluded. Body mass index (BMI) and classic
cardiovascular risk factors were recorded. Blood samples were analysed for glucose, lipid
profile, ESR, hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha),
interleukin-6 (IL-6) and IL-17. The homeostasis model assessment model for insulin
resistance (HOMA-IR) was used. The patients were randomized in a 1:1 ratio to receive
500mg/day retarded formulation of metformin (n=29) or placebo (n=29). Continuation of stable
doses of MTX (25mg/week), NSAIDs, and/or corticosteroids (prednisone <10 mg/day) was
permitted. Metformin drug pause on the day of MTX was given. Folic acid supplementation was
given to both groups. The primary clinical endpoint was the ACR 20% (ACR20) response at 24
weeks. Secondary endpoints included reduction in PASI score, Health Assessment
Questionnaire- Disability Index (HAQ-DI) and Psoriatic arthritis response criteria (PsARC)
score.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04152759 -
Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
| Completed |
NCT01925768 -
Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis
|
Phase 3 | |
| Completed |
NCT01892436 -
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
|
Phase 3 | |
| Completed |
NCT01212770 -
PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
|
Phase 3 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Completed |
NCT01212757 -
PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
|
Phase 3 | |
| Completed |
NCT03953378 -
CD73+ Th1.17 in Rheumatoid Arthritis and Psoriatic Arthritis
|
||
| Recruiting |
NCT02572700 -
Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis
|
||
| Completed |
NCT02556034 -
Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.
|
||
| Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
| Completed |
NCT01392326 -
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
|
Phase 3 | |
| Completed |
NCT02164214 -
Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?
|
Phase 3 | |
| Completed |
NCT01083693 -
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs
|
N/A | |
| Not yet recruiting |
NCT00517101 -
Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy
|
N/A | |
| Completed |
NCT00133315 -
TNFalfa Blocking Treatment of Spondylarthropathies
|
Phase 4 | |
| Completed |
NCT00659412 -
A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis
|
Phase 2 | |
| Completed |
NCT00946686 -
To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions
|
Phase 1 | |
| Not yet recruiting |
NCT06059430 -
Cohort Project of Patients With Inflammatory Rheumatism
|
||
| Completed |
NCT03736161 -
Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis
|
Phase 3 |