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The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations.
The purpose of this study is to create and test a patient decision aid that facilitates the shared decision-making process when patients with psoriasis and/or psoriatic arthritis are starting or switching to a new therapy.
Title Safety and Efficacy of Tofacitinib vs Methotrexate in the treatment of Psoriatic Arthritis- An Open Label Randomized single center study Psoriatic arthritis is defined as an inflammatory arthropathy associated with skin psoriasis and usually negative for rheumatoid factor. Till date, many NSAIDs, corticosteroids, DMARDs have been used, but the safety and efficacy issues demands more researches. The prevalence of PsA worldwide is about 1%-2% and among patients with psoriasis ranges from 7% to 42%. The pathogenesis of PsA involves many cytokines. Tofacitinib is an oral Janus Kinase (JAK) inhibitor with immunomodulatory and anti-inflammatory mechanism. It binds to JAK and prevents the activation of the JAK-signal transducers and activators of transcription (STAT) signaling pathway which ultimately decreases the production of pro-inflammatory cytokines, and prevents both inflammatory response and the inflammation-induced damage. It has shown better efficacy in many diseases like Rheumatoid Arthritis, Axial spondyloarthropathies, Psoriasis, Psoriatic Arthritis, Alopecia areata, dry eye disease. This prospective, open label, randomized study will be conducted in inpatient and outpatient departments of Rheumatology, BSMMU, Dhaka, Bangladesh in 110 adult volunteers (>18 years) of both genders diagnosed as psoriatic arthritis. Patients will be divided equally into two groups, Group A will be put on Tofacitinib 5 mg twice daily and Group B will be put on Methotrexate weekly in increasing dose with maximum dose of 25 mg weekly. Groups will be divided on the basis of randomization by random number table. Patients with inadequate response to highest dose of MTX or Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 5 mg BD or Tofacitinib 10 mg BD respectively. The patients not eligible for therapy will not be included in the study. Patients will be followed up at 1, 3 and 6 months. Baseline characteristics will be monitored and recorded at 3 and 6 months. The clinical information of the study subjects will be recorded in a structured history, clinical examination and questionnaire. All subjects will be enrolled after having informed written consent. The participants will enjoy every right to participate or withdraw from the study at any point of time. Response to Tofacitinib will be expressed in mean, standard deviation and percentage. Ethical clearance will be taken from the Institutional Review Board (IRB) of BSMMU.
Rheumatoid arthritis (RA) is a systemic disabling inflammatory disease, of autoimmune origin characterized by chronic synovial inflammation resulting in joint damage. Treg cell function in patients with active RA is assumed to be impaired, a trend that seems to be reversed by TNFalpha antagonist therapy. Remission is the current treatment goal in RA. An increasing number of patients in clinical trials achieve this goal raising the question whether patients who have been in remission for a prolonged period (sustained remission) still need medication indefinitely. From a decade TNF-blocker therapy have represented a new treatment option for RA patients non responders to conventional DMARDs and some evidence are now available showing that sustainable remission can be maintained achieved after withdrawal of TNF blocker. Objectives: to verify whether in RA patients in prolonged clinical and instrumental remission the percentages of CD4+CD25highCD127low/- T cells could represent a reliable marker of immunological remission and, even more relevant, if the pharmacological reconstitution of this "immune-modulator" Tcell population could contribute to better identify patients with a low risk of relapse after cessation of TNF-blocker therapy. Methods: in RA patients, who fulfilled the 1987 ACR revised criteria, with disease duration ! 5 years, clinical [Disease Activity Score on 28 joints-DAS28 0.56 ×√(TJC28) + 0.28×√(SJC28) + 0.70×ln(ESR) + 0.014×GH.TJC= Tender Joints Count (from 0 to 28); SJC= Swollen Joints Count (from 0 to 28) ESR=Erythrocyte Sedimentation Rate GH= patient's assessment of general health (VAS range from 0 to 100 mm); disease's flare was considered if: DAS44 >=2.4/DAS28 >=3.2.)], instrumental (joint ultrasonography: sites to be explored wrists are II-III metacarpophalangeal joint bilaterally using Power Doppler signal (grading 0-3); any other joint will be studied if symptomatic) and immunological (circulating CD4+CD25highCD127low/-Tcells and inflammatory cytokines levels) examination will be performed in order to asses, at different levels, disease activity status. Expected results: to identify in RA patients treated with anti-TNF an "exit-strategy" from these drugs based on clinical, imaging and immunologic features indicative of a sustained remission and to verify whether such conditions are able to predict a low incidence of relapse.
Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24 weeks.
Juvenile idiopathic arthritis (JIA) is one of the most common rheumatic diseases in childhood, affecting at least 1 in 1000 children. Children with JIA experience joint inflammation and swelling, pain and tenderness, morning stiffness, limited mobility. Children with JIA complain pain and have lower functional ability and decreased quality of life compared with their peers. Many studies have reported that patients with JIA have low physical activity levels and also exercise therapy is considered an important component of the treatment of JIA. Nowadays, studies for evaluating exercise behaviours in order to cope with physical inactivity for many chronic diseases are becoming increasingly important.The objective of this study is to determine exercise behaviour in patients with JIA.
The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice.
This study aims to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on the initial start of a combination of conventional and biological DMARDs (step-down strategy).
This study is a multicenter, prospective, non-randomized, non-controlled, single cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate in primary and revision reverse shoulder arthroplasty.