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NCT ID: NCT01881308 Completed - Clinical trials for Rheumatoid Arthritis

Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis

ARCTIC REWIND
Start date: June 17, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of disease-modifying anti-rheumatic drugs (DMARDs) dose reduction in patients with rheumatoid arthritis (RA). Remission is the treatment target in RA, but knowledge about the best way to treat RA patients who achieve sustained remission is limited. DMARDs have potential serious adverse events, and biologic DMARDs are costly to the society. The objectives for ARCTIC REWIND are to assess the effect of tapering and withdrawal of DMARDs on disease activity in RA patients in sustained remission, to study predictors for successful tapering and withdrawal of DMARDs in this patient group, and to study cost-effectiveness of different treatment options in RA remission. ARCTIC REWIND is a randomized, open, controlled, parallel-group, multicenter, phase IV, non-inferiority strategy study. Patients with less than five years of disease duration and stable remission for at least 12 months are randomized to either continued stable treatment or tapering and withdrawal of DMARDs, including tumor necrosis factor (TNF) inhibitors and synthetic DMARDs. Patients are assessed by clinical examination, patient reported outcome measures, ultrasonography, MRI and X-ray, and monitored for adverse events. The primary endpoint of the study is the proportion of patients who are non-failures (have not experienced a flare) at 12 months. Secondary endpoints include composite disease activity scores and remission criteria, joint damage and inflammation assessed by various imaging modalities, work participation, health care resource use and health related quality of life.

NCT ID: NCT01878123 Completed - Clinical trials for Rheumatoid Arthritis

Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

Start date: April 2013
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.

NCT ID: NCT01877668 Completed - Psoriatic Arthritis Clinical Trials

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

OPAL BROADEN
Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.

NCT ID: NCT01877239 Completed - Clinical trials for Rheumatoid Arthritis

Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria

Start date: December 10, 2012
Phase:
Study type: Observational

This is a prospective non-interventional observational study to evaluate the treatment of moderately active RA patients in every day clinical practice in Austria. Patients will be observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks.

NCT ID: NCT01875991 Completed - Clinical trials for Rheumatoid Arthritis

Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

Start date: June 5, 2013
Phase: Phase 4
Study type: Interventional

The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.

NCT ID: NCT01874067 Completed - Clinical trials for Rheumatoid Arthritis

C-GLOVES: the Effectiveness of Compression Gloves in Arthritis

C-GLOVES
Start date: October 2013
Phase:
Study type: Observational

This is a collaborative study with 11 Occupational Therapy (OT) departments in North-West England. The OTs provide arthritis gloves to 25% of out-patients with inflammatory, rheumatoid and osteoarthritis. The pressure applied by the glove(s) may help relieve hand pain, swelling and stiffness. People find they help but there is little research testing this. Of the five small studies published: two found little or no benefit; one found similar effects from arthritis and ordinary thermal gloves; two found some benefits. Testing if gloves work helps therapists and patients judge if they will help. This is a feasibility study to help us plan a future trial testing if arthritis gloves work for people with arthritis. We aim to find out: the rate we can recruit people to the study; if OTs can assess people's hands and provide gloves as agreed; how many people do we need to take part in a trial; what do people think (if any) is the gloves' most important effect and how long should we test them for? We will analyse the data to see what effect the gloves have. The study will last 12 months. People will get arthritis gloves as part of their usual care. The OTs have agreed a standard way of assessing and providing the gloves to ensure best practice across departments. The assessments include: difficulties using hands, pain and stiffness levels, and measuring hand and finger joint size and movement. People can take part if they: have one of the three types of arthritis; are willing to wear Isotoner three-quarter length gloves; can attend the usual 4 week review appointment for re-assessment; will allow us to use their anonymized hand assessments. We will also interview some people about their views of the assessment and their treatment. Each patient will be involved for 4-8 weeks.

NCT ID: NCT01873625 Completed - Clinical trials for Rheumatoid Arthritis

Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis

Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Osteoarthritis of the knee is one of the most common causes of disability among elderly. Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in 60 patients with knee osteoarthritis.

NCT ID: NCT01873443 Completed - Clinical trials for Rheumatoid Arthritis

Long-Term Efficacy and Safety of CT-P10 in Patients With RA

Start date: May 2013
Phase: Phase 1
Study type: Interventional

This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1

NCT ID: NCT01871961 Completed - Clinical trials for Rheumatoid Arthritis (RA)

Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient

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

To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).

NCT ID: NCT01871649 Completed - Psoriatic Arthritis Clinical Trials

Initial Treatment With Golimumab in Early PsA

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate alone is started. Golimumab will be discontinued. Hypotheses: First, the investigators hypothesize that initiation of a combination therapy with golimumab + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the percentage of patients achieving Disease Activity Score (the investigators hypothesize that more patients with the early combination treatment will respond (according to Disease Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal Disease Activity (MDA) than patients on MTX alone. Third, the investigators hypothesize that a significant proportion of the patients will continue to benefit from this early aggressive treatment initiation even after stopping golimumab treatment.