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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT03832374 Completed - Clinical trials for Rheumatoid Arthritis

Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis

ACPPPA
Start date: June 2, 2016
Phase:
Study type: Observational

Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial pneumopathy and bronchial disorders. According to the literature review, the prevalence of PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is responsible for a significant morbidity and mortality, is currently under-diagnosed and its treatment is poorly codified. The lung seems to have a central role in the genesis of rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide antibodies are preferentially present in the lungs. The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary airways. Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects with rheumatoid arthritis.

NCT ID: NCT03830203 Completed - Clinical trials for Rheumatoid Arthritis

Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Start date: December 19, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group, active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared with RoActemra in subjects with RA that is inadequately controlled by MTX. The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.

NCT ID: NCT03828344 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis

Start date: July 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, randomized, placebo-controlled, double-blind, single-dose, clinical trial examining the safety and biological effects of allogeneic fresh human umbilical cord tissue-derived mesenchymal stem cell product BX-U001, given by intravenous (IV) infusion, to rheumatoid arthritis (RA) patients with moderate to severe disease activity, who are not well controlled by their current treatments. Two doses of BX-U001 will be tested in 16 patients. The subjects will receive a one-time IV infusion of BX-U001 and monitored for 52 weeks.

NCT ID: NCT03827148 Completed - Clinical trials for Rheumatoid Arthritis

Impact of Pharmacist Intervention on Disease Knowledge, Rehabilitation and Medication Adherence, Treatment Induced Direct Cost, Health-related Quality of Life and Satisfaction in Patients With Rheumatoid Arthritis

DRAMATIC
Start date: November 17, 2018
Phase: N/A
Study type: Interventional

The objective of this study was to evaluate effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health related quality of life and direct cost of treatment. The study also documented patient satisfaction with pharmacist counselling as a quality control measure. This is a randomized controlled single-blind two-arm trial in patients with rheumatoid arthritis in Karachi, Pakistan. The study will enroll patients with established diagnosis of rheumatoid arthritis over three months. The patients after signing written consent would be randomized through a computer-generated list in control group, i.e., usual care and intervention group, i.e., pharmaceutical care with a ratio of 1:1. The study will take place in three patient-visits over the course of three months. The patients would be intervened by pharmacist in intervention group while those in control group will have usual care. Primary outcomes include change in mean score at follow-up, i.e., week 12, for disease knowledge, adherence to medications and rehabilitation/physical therapy, health related quality of life (HRQoL). The secondary outcomes include change in the mean direct cost of treatment and patient satisfaction from pharmacist counselling. This is a novel study that evaluates the role of pharmacist in improving treatment outcomes of patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for such patients in Pakistan. The results of this trial would be published in a peer-reviewed journal.

NCT ID: NCT03823391 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Start date: March 27, 2019
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03823378 Terminated - Clinical trials for Rheumatoid Arthritis (RA)

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

Start date: May 13, 2019
Phase: Phase 2
Study type: Interventional

This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib [ELS]) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).

NCT ID: NCT03821090 Completed - Clinical trials for Rheumatoid Arthritis

Rheumatoid Arthritis Disease Activity and Sub Clinical Atherosclerosis

Start date: April 15, 2019
Phase:
Study type: Observational

RA is associated with traditional cerebrovascular risk factors as subclinical atherosclerosis. Chronic inflammation and high disease activity are associated with atherosclerotic burden, higher incidence of cerebrovascular disease ,chronic heart failure , and mortality of patients with RA . High-sensitivity cardiac troponin I (hs-cTnI) predicted a greater risk coronary heart disease, heart failure hospitalization and overall mortality in the general population . So the aim of the study is to correlate between high sensitive cardiac troponin I , TNF-α to disease activity and presence of subclinical atherosclerosis in RA patients

NCT ID: NCT03815578 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients

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

Persistent pain and chronic fatigue are very common complaints in rheumatoid arthritis (RA) patients, whatever the anti-inflammatory treatment response. Interestingly, pain remaining despite good clinical response was associated with high disability and low inflammation at baseline, suggesting a mechanism of pain independent of inflammation in these patients. Such patients, with discordantly high patient-reported DAS28 components, fatigue and mood disturbance might represent a subgroup of RA patients who have specific clinical needs, not resolved by classical conventional or biologic DMARDs. In this way, neuropathic pain and pain sensitization have been demonstrated in 20 to 30% of RA patients, neuropathic pain scores being associated with worsen disease activity scores. Thus, pain sensitization may contribute to amplification of pain in active RA, and should be responsible for persisting pain and fatigue even after inflammation has resolved. Pain sensitization is associated with neuroplastic changes in sensory pathways at peripheral and central levels. Interestingly, major mediators responsible for this neuroplasticity operate via a JAK/STAT signaling pathway, which is specifically targeted by new RA treatments. New drug targeting JAK/STAT signalling pathway have been recently designed for RA treatment, based on the implication of this pathway on the signaling of various cytokines implicated in the pathophysiology of RA, such as IL-6, IL-12, IL-23 and IFNs. Two Jak-inhibitors have been put on the market: Tofacitinib and Baricitinib. In randomized clinical trials, Tofacitinib have shown a remarkable efficacy on pain and other patient reported outcomes, suggesting a specific effect or jak-inhibitors on pain control. Recent data suggest that Jak-inhibitors could have a direct effect on sensory neurons.

NCT ID: NCT03813771 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification

TEEMS
Start date: March 2019
Phase: Phase 4
Study type: Interventional

The main aim of the study is to determine the clinical utility of naive T-cell stratification for rationalising treatment with methotrexate (MTX), for DMARD-naive early RA patients. Thus, it aims to determine whether TNFi therapy (Benepali) instituted as first-line therapy in DMARD-naive early RA patients with poor T-cell prognostication confers better outcomes (clinical, structural and immunological). Hence, this would enable early targeted treatment for those with a poorer prognosis based on their immunological status.

NCT ID: NCT03813199 Completed - Clinical trials for Rheumatoid Arthritis

Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

Start date: July 4, 2019
Phase: Phase 2
Study type: Interventional

This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNFα) therapies.