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Patients with axial spondyloarthritis and high disease activity treating with systemic glucocorticoids: a double-blinded randomised controlled trial

To investigate the potential role of systemic glucocorticoids in patient with axial spondylarthritis with high disease activity.

Longstanding Exercise Therapy in Patients with axial Spondyloarthritis

This study aims to underpin the delivery of longstanding exercise therapy in the subgroup of patients with axSpA and complex disability.There are 2 research questions to be addressed 1. Is longstanding, optimized active exercise therapy more…

A phase-3, randomized, double-blind, study comparing Risankizumab to Placebo in subjects with active psoriatic arthritis (PsA) who have a history of inadequate response to or intolerance to at least on disease modifying anti-rheumatic drug (DMARD) therapy (KEEPsAKE 1)

The primary objective of the study is to compare the efficacy of risankizumab versus placebo for the treatment of signs and symptoms of PsA in subjects who have a history of inadequate response to or intolerance to at least one conventional…

A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis

The purpose of this study is to demonstrate the impact on progression of structural damage in the spine as measured by the mSASSS in patients with AS. Data from this study will be used to support the submission of an AS label extension to include a…

Induction of Cure in Early Arthritis. A single blind randomized clinical trial.

Primary Objectives: * to establish - which is the best treatment, MTX or baricitinib, to ensure rapid symptom relief of recent onset UA, based on clinical and patient reported outcomes from baseline to 3 months. Secondary Objective: * to establish…

EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS

Primary:* To assess the sustained efficacy of tofacitinib versus placebo in sJIA patients, as measured by time to sJIA flare in the double-blind randomized withdrawal phase.Secondary:* To assess efficacy of tofacitinib versus placebo in sJIA…

Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

This study has been transitioned to CTIS with ID 2023-503435-17-00 check the CTIS register for the current data. Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis (JPsA) in pediatric subjects…

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

This study has been transitioned to CTIS with ID 2024-513545-37-00 check the CTIS register for the current data. The main objective is to study the efficacy of treatment with RTX in patients with relapsing PMR compared to placebo.

A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT 494) to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

Main objective:1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-…

REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica

This study has been transitioned to CTIS with ID 2024-513544-28-00 check the CTIS register for the current data. The main objective is to study the efficacy of treatment with RTX in patients with newly diagnosed PMR compared to placebo.

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis.

The primary objective of the study is to evaluate the long-term safety and tolerability of baricitinib in patients who have completed a previous baricitinib RA study. Safety and tolerability assessments will include:* Treatment-emergent adverse…

Scorpio NRG® prospective, open-label, post-market international
multicentre outcome Study

The objective of this study is to collect basic function and patient satisfaction datafor observation and analysis.Specific objectives include the following:Evaluate the effect of component design on functional performance by comparing…

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis

Main objectives:1. To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms as measured by proportion of subjects who achieve an Assessment of SpondyloArthritis international Society (ASAS) 40 response at…

Platelet Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): A multi-center, stratified, block-randomized, double-blind, placebo-controlled trial

The goal of this study is to determine the efficacy of PRP injections in the management of ankle osteoarthritis by comparing 2 groups: One receiving a PRP injection and the other a saline solution.

Duloxetine for chronic osteoarthritis pain; an important alternative?

The objective of this proposal is to investigate if duloxetine is effective as a third choice pain medication for treating chronic pain in OA compared to usual care. Furthermore, we will assess the cost-effectiveness of duloxetine treatment and if…

A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab monotherapy in patients with active psoriatic arthritis

The purpose of this study is to compare the safety and efficacy of secukinumab monotherapy and adalimumab monotherapy in patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy for PsA or PsO and are intolerant or having…

A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients with Axial Spondyloarthritis

Primary objective:-To evaluate in patients having achieved a state of sustained remission whether the ixekizumab treatment group is superior to the placebo group in maintaining response during the randomized-withdrawal periodSecondary objectives:-To…

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…

A 52-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab versus Adalimumab in Patients with Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

Primary objective:-To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by American Collegeof Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI 100)Major…

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…