A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
Adult Onset Rheumatoid ArthritisThe purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (RA).
Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo...
Rheumatoid ArthritisThe purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy. The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy.
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending...
Rheumatoid ArthritisA study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD9567.
MTX Discontinuation and Vaccine Response
ArthritisRheumatoidTo investigate whether a short term discontinuation of methotrexate (MTX) will improve the vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease activity in a randomized clinical trial.
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan®...
Rheumatoid ArthritisThe study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.
An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects...
Rheumatoid ArthritisThis was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and assessment period of one of the preceding Phase IIb studies with ALX-0061 (ALX0061-C201 and ALX0061-C202; placebo and ALX-0061 treatment arms only), and who achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) (66/68 counts) compared to Baseline at the final visit of the preceding study (i.e., Week 24 for Study ALX0061-C201 and Week 12 for Study ALX0061-C202).
The Effects of a Six-week Exercise Programme Undertaken by Women With Rheumatoid Arthritis
Rheumatoid ArthritisPhysical ActivityThis study is investigating whether a six-week exercise training programme, designed for patients with Rheumatoid Arthritis, improves disease activity, inflammation, cardiorespiratory fitness, muscle strength, flexibility and risk factors for cardiovascular disease. Twenty four patients will be randomly assigned to an intervention or control group (n=12 in each group). The intervention group will will undertake a fully supervised structured exercise training programme, consisting of both aerobic and strength training exercise, taking the form of two 70-minute group fitness classes per week for six weeks. These participants will also undertake a 30-minute walk in their own time. The control group will continue to go about their normal daily activities. Measurements will be made before and after the intervention/control period, including assessments of disease activity (e.g., by gauging how swollen and tender patients' joints are using the Disease Activity Score(DAS) ) and assessments of fitness and/or physical functioning (e.g., 200 meter timed walk test, a strength test, a flexibility test, Health Assessment Questionnaire Disability Index (HAQDI)). Blood samples will also be collected from patients before and after the intervention/control period to measure markers of inflammation, such as C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR). The investigators will also measure other parameters that are linked to type II diabetes (e.g., fasting glucose concentration) and factors implicated in cardiovascular disease risk (e.g., lipid profile and resting blood pressure).
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers...
ArthritisRheumatoidThis double-blind, placebo-controlled, multiple ascending dose study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of SKI-O-703 in healthy volunteers.
Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol...
Moderate and Severe Active Rheumatoid ArthritisActive Psoriatic Arthritis2 moreThe purpose of the study is to evaluate the ability of subjects who are already prescribed Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least the previous three months, to safely and effectively self-inject Certolizumab Pegol (CZP) using the e-Device and to evaluate the post-use structural integrity of used devices and cassettes via visual examination.
Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With JIA and...
Juvenile Idiopathic ArthritisArthritis in children is a long-term illness and it can make a child's life very difficult. In children 8-11 years old, the child and their family work together to deal with the problems that arthritis can cause. Learning to cope with and manage the problems that come with arthritis can stop it from getting worse. It is important to create programs that teach children and families how to cope with and manage arthritis. This study will develop and test an online game that helps children learn how to better manage their arthritis. The goal of these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if children who play the game feel less pain, have fewer limitations, and a better quality of life compared to children who do not play the game.