Active clinical trials for "Arthritis, Rheumatoid"

CR6086 is a new, potent and selective, orally available, small molecule prostaglandin EP4 receptor antagonist, endowed with immunomodulatory properties. The pharmacological properties of CR6086, along with its oral bioavailability, predictable pharmacokinetics and good safety, make it the ideal candidate to be tested alone or in combination with methotrexate (MTX) in patients with early Rheumatoid Arthritis who are naïve to Disease-Modifying Antirheumatic Drugs (DMARDs). The compound has indeed the potential to provide a safer and more effective treatment than MTX (or other conventional synthetic DMARDs - csDMARDs), and could significantly improve the proportion of responder patients and avoid/delay the recourse to biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs).

This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.

This is a phase 2a study to be run in 2-3 countries in European Union involving 5-6 sites. It will enroll approximately 80 patients to ensure 40 randomized with active rheumatoid arthritis. The treatment period is 2 weeks and total study duration per patient is approximately 1 month. The study drugs are AZD9567 40 mg (an oral SGRM) and the comparator is prednisolone 20mg. The primary endpoint is DAS28 including evaluation of 28 joints and C-reactive protein. Safety parameters will also be evaluated and a biomarker program is included for future research.

The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic function relative to matched, healthy controls.

This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study.

Rheumatoid arthritis (RA), a chronic, inflammatory condition with increased mortality from cardiovascular disease, is associated with high health care related costs and decreased productivity. Currently, nonpharmacological management guidelines recommend increasing low levels of physical activity in this group to improve health including cardiovascular health, yet research has shown that people who have RA have reduced levels of PA. Interventions targeting PA behaviour in this population have had limited effect to date due to lack of patient involvement in designing the intervention, poor measurement of PA, lack of behaviour change theory underpinning the intervention and have tended to include people who already have some level of PA. Work to underpin a robust intervention to improve PA in this group has been undertaken by members of this study group including validation of an objective measure PA in RA and interviews with people who have RA and rheumatology health professionals to aid in designing an intervention to promote PA. The aim of this pilot randomised controlled trial (RCT) is to examine the feasibility of a physiotherapist led, behaviour change theory informed, PA intervention to promote PA in people who have RA who have low levels of current PA. This pilot study will determine the rate of recruitment to the study and also determine the acceptability of the intervention to the participants as well as test the feasibility of the secondary disease/PA focused outcome measures. Participants will be recruited from rheumatology clinics in a large teaching hospital. Participants meeting inclusion criteria will be randomised into an eight week PA intervention (four sessions delivered over an eight week period by a trained physiotherapist) or a control group (PA information leaflet). This pilot randomised study will provide valuable information for the scaling up of a primary care based intervention for this important patient group and in doing so provide an achievable, pragmatic intervention for busy clinicians, who need feasible interventions to appropriately manage complex chronic conditions like RA in a busy primary care setting.

Rheumatoid arthritis (RA) patients in remission with a combination of TNFinhibitors (TNFi) and methotrexate (MTX) often express their wish to stop MTX treatment because of side effects. Given the efficacy of TNFi it is conceivable that in early RA patients in remission with methotrexate (MTX)/TNFi stepwise discontinuation of MTX prior to TNFi is superior in maintaining sustained remission and reaching drug free remission as compared to discontinuation of TNFi prior to MTX. Objective: To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission. Study design: multicenter, open label clinical trial in very early RA patients. Remission will be induced by an open label treat-to-target (T2T) remission induction protocol in clinical care: (MTX, hydroxychloroquine (HCQ), i.m. glucocorticoids (GC), and, if not in remission, the TNFi golimumab (GOL)) (phase I, 3/4th or 1 year). Patients in sustained remission on MTX/GOL (DAS28<2.6 with max 4 swollen joints of the 44 swollen joint count (SJC) at 2 consecutive visits 3 months apart) will be randomized to taper either MTX first, then GOL or GOL first, then MTX with as primary endpoint sustained (drug free) remission (phase II, 1 year). During 1 year additional follow-up maintenance of drug-free sustained remission will be investigated (phase III). Study population: RA patients fulfilling 2010 American College of Rheumatology (ACR)/EUropean League Against Rheumatism (EULAR) criteria for RA, with symptom duration <12 months; naïve for anti-rheumatic drugs and glucocorticoids for RA; DAS28 ≥3.2. Intervention: Patients in sustained remission (defined as DAS28<2.6 with max 4 swollen joints of the 44SJC at ≥ 2 consecutive visits 3 months apart) on MTX/GOL at the end of phase I (after 24 weeks of treatment with MTX/GOL) will be randomized in a ratio of 1:1 to taper medication as follows: Taper and stop GOL first during 24 weeks, then, if still in sustained remission, taper and stop MTX during 24 weeks Taper and stop MTX first during 24 weeks, then, if still in sustained remission, taper and stop GOL during 24 weeks The primary end point is the proportion of patients in sustained remission at week 24 after start of tapering of either MTX or GOL first. The main secondary end point is the proportion of patients in drug-free sustained remission, at week 48 after start of tapering.

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.

This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.

Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial joints and tendon sheaths. As a result of synovitis, progressive damage occurs in cartilage, bone and joints. This damage leads to severe functional limitations and deterioration in quality of life. Synovial tissues are the main site of involvement. Manual lymph drainage reduces the levels of inflammatory mediators associated with edema and pain in the acute phase. On the basis of this concept; Stimulating the lymph system and increasing circulation, removing biochemical residues, regulating sympathetic and parasympathetic system responses, and thus reducing edema and pain. The increase in cardiac parasympathetic activity measured after MLD also contributes to relaxation. In addition to the transport of lymphatic fluid, manual lymph drainage stimulates free nerve endings in the skin with the touches it contains. Gentle stimulation to the skin increases tactile input and closes the pain pathways. In addition, the superficial relaxation and warming provided by soft stimulation creates an effect on the autonomic nervous system and activates the parasympathetic system. The aim of this study is to evaluate the effect of manual lymphatic drainage on upper extremity functionality in individuals with rheumatoid arthritis.