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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT05554705 Terminated - Clinical trials for Rheumatoid Arthritis

Lifestyle Intervention for Rheumatoid Arthritis

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.

NCT ID: NCT05269069 Terminated - Clinical trials for Rheumatoid Arthritis

Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study

RAFAT
Start date: August 17, 2022
Phase:
Study type: Observational

During rheumatoid arthritis (RA) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass. Determination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular (excess cardiovascular risk), metabolic (insulin resistance, diabetes and dyslipidemia) and bone (increased fracture risk) risks associated with this endocrine organ. Moreover, we do not have data concerning medullary adiposity in RA. This pilot case-control study will be compare body composition, bone marrow adiposity and bone mineral density in patients with RA versus healthy volunteers.

NCT ID: NCT05238896 Terminated - Clinical trials for Rheumatoid Arthritis

BARIcitinib Cognitive Emotional and Neural signaTuRE

BARICENTRE
Start date: June 27, 2022
Phase: Phase 4
Study type: Interventional

Rheumatoid arthritis (RA) is a frequent and disabling disease, requiring early management to achieve clinical remission. Recently, baricitinib (jak1-jak2 inhibitor) has been shown to as an efficient treatment in placebo-controlled trials, and compared to the reference treatment with TNF inhibitor (adalimumab). Its efficacy has been reported on the inflammatory parameters, but more importantly on patient-reported outcomes. Baricitinib is thought to have anti-inflammatory effects, via its inhibition of the JAK pathway. Importantly, it has also been suggested to affect mood and pain. Hypotheses: Inhibition of JAK Kinase pathway in patients with RA will improve emotional and cognitive processing involved in mood disorders and decrease pain sensitization. The primary objective of this study is to evaluate early emotional impact of the JAK 1/2 inhibitor Baricitinib assessed by a facial emotion recognition task. This precocious effect on emotion processing is a surrogate marker of clinical imporvement in mood. Phase 4 study, Double-blind randomized control study with patients receiving placebo or baricitinib for 7 days, then open label study until day 42 with all patients receiving baricitinib during 5 weeks.

NCT ID: NCT05116228 Terminated - Clinical trials for Rheumatoid Arthritis

Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission

REDOREM
Start date: September 1, 2015
Phase: Phase 4
Study type: Interventional

To investigate whether a reduced-dose dosing regimen (1x500mg semiannually) of rituximab (RTX) (Mabthera®) is non-inferior in patients with rheumatoid arthritis (RA) whose disease is in persistent low disease activity (LDA) or clinical remission (REM) (pLDA/pREM) as compared to the standard dosing regimen of 1x1000mg semi-annual infusions.

NCT ID: NCT04888585 Terminated - Clinical trials for Rheumatoid Arthritis (RA)

Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)

Start date: June 2, 2021
Phase: Phase 2
Study type: Interventional

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors place the participants in 1 of 5 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Participants 18-75 years of age with moderate to severe RA will be enrolled. Around 425 participants will be enrolled in the study in approximately 270 sites worldwide. The study is comprised of a 12-week placebo-controlled period, a double-blind long-term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group will be re-randomized to receive ABBV-154 in 2 different doses SC every other week (eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04842981 Terminated - Clinical trials for Arthritis, Rheumatoid

Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis

Start date: May 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

With this study the investigators aim to assess if drug metabolism changes in patients with rheumatoid arthritis when an interleukin (IL)-6 inhibitor is initiated. Patients with rheumatoid arthritis have an increased level of inflammation in the body which can lead to decreased expression and activity of drug metabolizing enzymes in the liver. This will lead to a decreased metabolism and excretion of drugs. The inflammation is driven by a number of proinflammatory cytokines e.g., IL-6. The investigators hypothesize that patients with rheumatoid arthritis initiating treatment with an IL-6-receptor inhibitor (anti-IL-6R) will obtain a normalization of the activated IL-6-pathway resulting in increased expression and activity of drug metabolizing enzymes and hence increased metabolism. Ultimately, this normalization of drug metabolism could lead to insufficient efficacy of a wide variety of drugs. The investigators will perform a clinical pharmacokinetic trial. The study will include patients with active rheumatoid arthritis and a need to initiate treatment with an IL-6 receptor antibody. Patients will ingest a 6-drug cocktail consisting of probes for specific CYP enzymes. Plasma and urine will be drawn over 6 hours to determine concentrations of the drugs and their metabolites. Patients will then initiate IL-6 receptor antibody treatment and to assess both short- and long-term impact of altered inflammation, the same 6-drug cocktail will be ingested, and concentrations measured, after three weeks and three months. To help understand the mechanism and the putative involvement of inflammation, markers of inflammation such as cytokines, transcription factors, etc. will also be assesses.

NCT ID: NCT04584541 Terminated - Clinical trials for Rheumatoid Arthritis

SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism

COVIRIC
Start date: June 11, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.

NCT ID: NCT04333147 Terminated - Clinical trials for Arthritis, Rheumatoid

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

contRAst X
Start date: May 12, 2020
Phase: Phase 3
Study type: Interventional

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

NCT ID: NCT04311567 Terminated - Clinical trials for Rheumatoid Arthritis

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

PULMORA
Start date: November 7, 2020
Phase: Phase 4
Study type: Interventional

Pulmonary abnormalities are present in up to 60% of patients with early rheumatoid arthritis (RA), and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indicate that inhibition of Janus kinase is beneficial for this extra-articular manifestation. Our goal is to determine whether tofacitinib is an effective and safe treatment, compared to standard-of-care methotrexate, for subclinical and clinical ILD in patients with early RA. The study also explores disease mechanisms in lungs and joints, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of RA-ILD.

NCT ID: NCT04309227 Terminated - Clinical trials for Rheumatoid Arthritis

Comparison of Training Load With/Out Blood Flow Restriction Training in Rheumatoid Populations

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The study will investigate the effects of a traditional, high-intensity strengthening program compared to an investigational low-intensity strengthening program that also uses blood flow restriction as part of the training program. Both groups will be compared to a control group, which will receive no training. Measures of strength, function, and patient outcomes will be taken before starting the training, at mid-term, and at the end of the 8-week training program. Additionally, investigators will collect outcome data at 6 and 12 months after completing the program to assess for long term outcomes. The eligible populations are participants with rheumatoid arthritis (RA), osteoarthritis (OA), or myositis. The study will include about 15 participants per group, or 45 people with each diagnosis.