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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT04004429 Completed - Clinical trials for Rheumatoid Arthritis

A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease

SynAct-CS002
Start date: August 26, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > 22, who are to start up-titration with methotrexate.

NCT ID: NCT04002765 Recruiting - Clinical trials for Rheumatoid Arthritis

Factors of ILD in Newly Diagnosed Rheumatoid Arthritis

FIND-RA
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

To determine factors associated with early RA-ILD (which may be asymptomatic). It is planned to recruit all patients with a newly diagnosed RA (symptoms since less than 3 years). In this study, all relevant demographic and clinical data will be collected. All patients will undergo lung function tests and high-resolution CT-scan of the lungs. Blood sample will be collected for measurement of (1) anti-CCP and rheumatoid factor measurement (good clinical practice) and a specific sample for the detection of the MUC5 promoter variant rs35705950. Our aim is thus to identify determinants of RA-ILD in the following population: - Adults aged 18 to 90 years-old - Diagnosis of rheumatoid arthritis (RA) based on ACR-EULAR 2010 criteria - Onset of disease duration at least 1 year and at most 10 years prior to inclusion

NCT ID: NCT03999528 Completed - Clinical trials for Rheumatoid Arthritis

14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis

Start date: May 1, 2019
Phase:
Study type: Observational

Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

NCT ID: NCT03995615 Recruiting - Clinical trials for Periodontitis and Rheumatoid Arthritis

ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40

Start date: January 2020
Phase: N/A
Study type: Interventional

The presence of YKL- 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the gingival crevicular fluid YKL-40 levels in healthy patients, chronic periodontitis and patient with chronic periodontitis having rheumatoid arthritis at baseline and chronic periodontitis having rheumatoid arthritis 6 weeks post periodontal therapy (scaling and root planning [SRP]). This could throw more light on it and extend our knowledge on its role in both the conditions.

NCT ID: NCT03993548 Completed - Healthy Clinical Trials

KickStart30: A 30-Day Intervention for Patients With Rheumatoid Arthritis (RA)

KickStart30
Start date: June 17, 2019
Phase: N/A
Study type: Interventional

This study explores the efficacy and feasibility of a self-management wellness intervention that is integrated, prescriptive, and trackable in a population of patients with Rheumatoid Arthritis (RA) taking a biologic. This 30-day wellness intervention (called "KickStart30") combines five wellness elements: exercise, mindfulness, sleep, social connectedness, and nutrition. Additionally, the program requires that participants implement 5 wellness interventions daily for the 30-day study, document daily online adherence, complete daily HERO (happiness, enthusiasm, resilience, and optimism) exercises to improve mental wellness, and complete online program forms before and after the 30-day intervention. Participants are assessed pre- and post-intervention to determine whether the intervention promotes wellness behavior changes.

NCT ID: NCT03992781 Completed - Clinical trials for Rheumatoid Arthritis

Changes of Depression After First-year of Tofacitinib in RA Patients

Start date: July 23, 2020
Phase:
Study type: Observational

12-month, single arm, prospective, non-interventional, multi-center study according to Czech legal definitions (Law 378/2007 Sb.).The primary objective of this study is to describe and evaluate the changes of depression level within 12 months from the start of tofacitinib therapy in patients with RA and at least minimal level of depression. Primary goal is to find out if treatment by tofacitinib reduces the depression by at least 10% during 12 months.

NCT ID: NCT03986918 Recruiting - Clinical trials for Rheumatoid Arthritis

Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System

Start date: June 1, 2019
Phase:
Study type: Observational

The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.

NCT ID: NCT03981900 Completed - Clinical trials for Arthritis, Rheumatoid

IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

Start date: January 4, 2019
Phase:
Study type: Observational

Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available. Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA. As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

NCT ID: NCT03980639 Recruiting - Clinical trials for Rheumatoid Arthritis

Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

Start date: November 20, 2018
Phase:
Study type: Observational

There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs), especially abatacept which compared to Tumor Necrosis Factor α (TNFα) inhibitors has distinct mechanism of action. Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and the Fc region of human immunoglobulin gamma-1 (IgG1). This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86. Recently, the investigator's study found in a US cohort of 64,000 patients with Rheumatoid Arthritis (RA) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs (article in press). These results were in accordance with another prospective cohort study of the public health care system in Sweden, showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors. As these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and NMSC, compared to other bDMARDs.

NCT ID: NCT03980483 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

contRAst 1
Start date: May 16, 2019
Phase: Phase 3
Study type: Interventional

This study [contRAst 1 (201790: NCT03980483)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. The study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with MTX. Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.