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Rheumatoid Arthritis (RA) clinical trials

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NCT ID: NCT06417138 Recruiting - Clinical trials for Rheumatoid Arthritis RA

"Comparative Effect of Different Drugs Used to Tr€at Patients in Rheumatoid Arthritis Saudi Database (RASD)"

Start date: December 15, 2023
Phase:
Study type: Observational

Comparative effectiveness of different drugs used to treat patients in Rheumatoid Arthritis Saudi database (RASD) Introduction Rheumatoid arthritis (RA) is a chronic inflammatory disease-causing significant disability among patients(1). The prevalence rate of RA varies based on the geographical locations, however, several reviews reported a global prevalence rate of 0.5-1.1% with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population(1,2). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis . In Saudi Arabia, recent and generalisable epidemiological data regarding RA in Saudi Arabia are limited and suboptimal(1). One study by Al Dalaan et al in 1998, that was conducted in Al-Qassim region reported that the prevalence rate of RA is about 0.2%(3). In patients with RA, early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state (4). However, the international lag time from the onset of symptoms until the initiation of treatment in patients with RA has been collectively calculated to be around almost one year time (5). Diseases modifying anti rheumatic agents (DMARDS) are the main drugs used for the management of RA, and it mainly reduce the inflammation and improve the outcomes(6). Several DMARSs drugs are available for the management of RA, however, recently, biological DMARDS have also been widely used and recommended in case the conventional DMARDS fail to control the diseases(6,7). Worldwide, there have been multiple studies that examined the effectiveness of DMARDS and bDMARDS drugs for the management of RA, this include large controlled trials which are the gold standard method for investigating medications efficacy(8,9). However, observational real-world data to examine the effectiveness of these medications is also important and can be more generalizable, have longer follow up and can examine different characteristics. Previous observational studies investigating the effectiveness of DMARDS and bDMARDS were mainly in Europe and North America which does not necessarily represent the current situation and the characteristics of the middle eastern population(10,11), as there is so much variability in access to different biological drugs in different countries. In addition, these studies did not compare treatment lines. In the middle east there were limited studies that addressed the effectiveness of different drugs used to treat RA in Saudi Arabia(5,12-14). These studies were mainly cross sectional in nature or reviews, and it is difficult to draw any conclusions with such study designs. Therefore, this research is to compare the effectiveness of multiple DMARDS medication for the treatment of RA patients in Saudi Arabia. Literature Review Rheumatoid arthritis (RA) is a chronic progressive inflammatory disease that causes irreversible joint deformities which can have debilitating effects on a patient's overall wellbeing. RA has a global prevalence rate of 0.5-1.1% with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population (1). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis. RA is strongly associated with the female gender, with a female to male ratio of 2:1 to 3:1. Smoking habits have also been shown to both increase the risk of acquiring RA and of worsening its prognosis(1,15). Early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state. A study found that only 31% of RA patients visited a rheumatologist within less than 12 weeks of symptom onset, those who did had ameliorated progression rates at 6 years as measured by the Sharp/van der Heijde score (SHS) as well as higher rates of DMARD-free remission than patients who delayed their presentation to more than 12 weeks (16) Even though the importance of optimal treatment has been demonstrated, in Africa and the Middle East diagnoses are often delayed for months or even years after symptom onset(5,12,17,18) Our group conducted a study in Saudi Arabia showed that patients may not receive a diagnosis of RA for up to 30 months after the onset of symptoms (12). Raising public awareness of RA and treatment options is also an important tool for reducing time to diagnosis(17). Public education programs can lead to earlier diagnosis and initiation of therapy, as observed in patients in the United Arab Emirates(19). Increased public awareness may also lead to patients with symptoms of RA visiting rheumatology clinics rather than other specialties, thereby receiving adequate and timely treatment. Delayed diagnoses can be attributed to a variety of reasons. In

NCT ID: NCT06055023 Recruiting - Clinical trials for Rheumatoid Arthritis (RA)

Study of Tolerability, Safety, and Pharmacokinetics of ZL-82 in Healthy Adult Subjects.

Start date: April 9, 2023
Phase: Phase 1
Study type: Interventional

ZL-82 is an oral janus kinase (JAK) inhibitor. In vitro biological mass spectrometry identification test proves that ZL-82 can selectively and irreversibly inhibit JAK3. It has obvious safety advantages, with a wide therapeutic window and controllable cardiotoxicity. This is also demonstrated from preliminary GLP-conditions of acute toxicity in SD rats and Beagle dogs. Results of 4-week long-term toxicity in Beagle dogs also support this notion. Therefore, ZL-82 has the potential to treat rheumatoid arthritis. It Used to relieve and heal swelling, pain, stiffness, and limited mobility that may be caused by rheumatoid arthritis.The drug is intended to be used in patients with RA to relieve and heal swelling, pain, stiffness, and limited mobility that may be caused by rheumatoid arthritis. Pharmacodynamic studies show that ZL-82 has a strong inhibitory effect on JAK3 with IC50 of 2.8 nM, and has no obvious inhibitory effect on JAK1, JAK2 and TYK2. Compared with the similar drug Tofacitinib, its inhibitory effect on JAK3 subtype is 1nM, but its inhibition IC50 for JAK1 subtype and JAK2 subtype are 112nM and 20nM, respectively.and its selectivity is 100-fold and 20-fold, respectively.Also, the selectivity multiples of ZL-82 were 100-fold and 20-fold than tofacitinib , respectively, which indicates that ZL-82 is more selective than the marketed Tofacitinib.This allows ZL-82 to precisely inhibit JAK kinase and block a series of cytokines in the downstream signaling pathway. And show significant effect on rheumatoid arthritis. The experimental results showed that in DTH and CIA models, 25, 50, 75, and 100 mg/kg of this variety could dose-dependently inhibit joint swelling in mice. Objectives of Study Main Purpose: 1. To evaluate the tolerability, safety and pharmacokinetic characteristics of a single oral dose of ZL-82 tablets in healthy adult subjects; 2. To explore the effect of eating on the PK of oral ZL-82 tablets in healthy adult subjects; 3. To evaluate the tolerability, safety and pharmacokinetics of ZL-82 tablets after multiple oral administration in healthy adult subjects.

NCT ID: NCT05588817 Recruiting - Clinical trials for Rheumatoid Arthritis (RA)

Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis

Start date: December 30, 2022
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) is known as a long-lasting inflammatory autoimmune disease affecting the diarthrodial joints, which is diagnosed by inflammation and hyperplasia in synovium, generation of RF and anti-citrullinated protein antibody (ACPA), deformity of cartilage and bone, systemic injuries involving cardiovascular, pulmonary, psychological, and skeletal disorders (McInnes and Schett., 2011).

NCT ID: NCT05486715 Not yet recruiting - Clinical trials for Rheumatoid Arthritis (RA)

Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients

Vitamind
Start date: September 1, 2022
Phase:
Study type: Observational

Vitamin D level and its association with disease activity in Egyptian Rheumatoid arthritis (RA) patients

NCT ID: NCT05421442 Active, not recruiting - Clinical trials for Rheumatoid Arthritis (RA)

A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database

DANBIO
Start date: June 13, 2019
Phase:
Study type: Observational

The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).

NCT ID: NCT05047341 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study of Human Substance Balance and Biotransformation of [14C]SHR0302

Start date: September 7, 2021
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the absorption, metabolism and excretion of [14C]SHR0302 in healthy Chinese adult male subjects.

NCT ID: NCT05000216 Completed - Clinical trials for Rheumatoid Arthritis (RA)

COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: - Systemic Lupus Erythematosus (SLE) - Juvenile Idiopathic Arthritis (JIA) - Pediatric-Onset Multiple Sclerosis (POMS) - Juvenile Dermatomyositis (JDM)

NCT ID: NCT04941729 Terminated - Hip Fractures Clinical Trials

Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System

OR3O
Start date: June 23, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets. Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative. Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery. Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation. 4 study sites in China.

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: NCT04574492 Active, not recruiting - Clinical trials for Rheumatoid Arthritis (RA)

A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis

CLOSEUP
Start date: October 7, 2020
Phase:
Study type: Observational

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA. Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada. Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.