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Arthritis clinical trials

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NCT ID: NCT02065713 Completed - Psoriatic Arthritis Clinical Trials

Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients

GO-DACT
Start date: August 2014
Phase: Phase 3
Study type: Interventional

Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy of synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has not been previously studied in randomized controlled trials as a primary endpoint. In this investigator initiated clinical trial the investigators aim to test the hypothesis that the combination therapy of golimumab and methotrexate (MTX) will result in a significant improvement of dactylitis in comparison with MTX monotherapy, in MTX naïve psoriatic arthritis patients, at week 24. Similarly the efficacy on enthesitis, peripheral and axial involvement, skin and nail psoriasis, inflammation and damage of the feet and hands assessed by magnetic resonance imaging (MRI), composite indexes of disease activity, remission, function and quality of life will be determined. This is a national multicentre, interventional, double-blinded, placebo-controlled, parallel design trial. 136 patients with active dactylitis, refractory to at least two systemic non-steroidal anti-inflammatory drugs (NSAIDs), at optimal dosage, for 3 months will be included and centrally randomized to golimumab in combination with MTX versus MTX monotherapy, in a 1:1 ratio. The study duration will be 24 weeks. The investigators expect the results from this trial will contribute to a better definition of the treatment algorithm of PsA patients with dactylitis.

NCT ID: NCT02065700 Completed - Clinical trials for Rheumatoid Arthritis

Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants

DARWIN3
Start date: February 25, 2014
Phase: Phase 2
Study type: Interventional

The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis. Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.

NCT ID: NCT02064400 Completed - Clinical trials for Rheumatoid Arthritis

Pilot Study of Ultrasound in Rheumatoid Arthritis

Start date: February 2014
Phase: N/A
Study type: Observational

Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made. This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.

NCT ID: NCT02058069 Completed - Clinical trials for Rheumatoid Arthritis

Robotic Arm Assisted Total Knee Arthroplasty

Start date: February 2014
Phase: N/A
Study type: Interventional

The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB). The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows: - Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up. - Secondary Objective: Radiographic assessment of post-operative limb alignment. - Supporting Objective: Patient assessment of post-operative function and satisfaction.

NCT ID: NCT02057250 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

SARIL-RA-EASY
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA) patients. Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

NCT ID: NCT02056184 Completed - Clinical trials for Rheumatoid Arthritis

Targeted Ultrasound in Rheumatoid Arthritis

TURA
Start date: December 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether therapy modifications (including addition of ultrasound-guided treatment change) can change imaging results in patients with early rheumatoid arthritis in a stable clinical disease activity state.

NCT ID: NCT02053727 Withdrawn - Clinical trials for Rheumatoid Arthritis

Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background

RA
Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether the combination of abatacept along with entecavir (the study drugs) is safe and effective in treating symptoms related to rheumatoid arthritis (RA). Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form, is approved by the FDA for the treatment of RA. In this research, abatacept will be given by injection. A subcutaneous injection is an injection given under the skin. Entecavir, to be taken by mouth, is approved by the FDA for the treatment of hepatitis B. The study is divided into the following time periods: Screening Phase: Up to 4 weeks Randomized Double-blind Phase: 24 weeks Open-label Extension Phase: 24 weeksFollow-up Phase: a phone call after Week 48 Each phase contains one or more study visits.

NCT ID: NCT02052609 Completed - Psoriatic Arthritis Clinical Trials

A Phase 3 Clinical Study of KHK 4827

Start date: February 2014
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

NCT ID: NCT02052375 Completed - Clinical trials for Rheumatoid Arthritis

A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate

Start date: June 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408.

NCT ID: NCT02052167 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis

Start date: April 2014
Phase: Early Phase 1
Study type: Interventional

This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label comprehension assessment and a device robustness evaluation).