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A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis (CBYM338B2203)

Primary: to demonstrate that at least one dose regimen of BYM338 in sporadic inclusion body myositis patients will increase the distance traveled as measured by change from baseline at Week 52 of the 6 minute walking distance test relative to…

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections

To assess the efficacy of secukinumab 300 mg s .c. vs. placebo in patients with overuse rotator cuff tendinopathy in relieving clinical symptoms at week 14

A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis

Voor meer informatie verwijs ik u naar sectie 2 in het protocol

The value of Autologous Tenocyte Implantation in patients with chronic Achilles tendinopathy: a double-blind randomised clinical trial

This study is designed to compare the treatment of 2 groups: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises.

Local Infiltration Anaesthesia in Total Hip Arthroplasty by Anterior Supine Intermuscular Approach

Determining the outcome of reversed and antegrade LIA in THA with ASI by analysing postoperative pain with the 100 mm Visual Analogue Scale (NRS), length of hospital stay, the amount of postoperative consumption of opioid pain medication as well as…

Efficacy, Safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain

To assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 µg, 400 µg, and 600 µg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the
Safety, Pharmacokinetics, and Efficacy of VX-509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying
Antirheumatic Drugs

1.1 Primary ObjectivesDuring 12 weeks of treatment in subjects with active RA on stable DMARD therapy:• To evaluate the efficacy of VX-509 across a range of doses• To evaluate the early effect of VX-509 administration on joint structures as assessed…

A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexia (CBYM338X2204)

Primary: Assess the effect of i.v. infusions of BYM338 on muscle volume of the thigh (assessed by MRI) at 4, 8, 16 and 24 weeks, compared to placebo, in COPD patients with pulmonary cachexia.Secondary: Effect on 6-minute walk test, safety and…

effect of the combination of green lipped mussel, curcumin and ribus nigrum (supplement Synofit) on quality of life and pain in patients with osteoarthritis of the knee

measuring the efficicy of the combination of green lipped mussel, curcumin and ribus nigrum (supplement Synofit) on quality of life and pain in patients with osteoarthritis of the knee

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF 3-MONTH SUBCUTANEOUS REGN1033 TREATMENT IN PATIENTS WITH SARCOPENIA

Please refer to protocol, section 1.2 "Rationale"

Effectiveness of radiotherapy in osteoarthritis of the hand and knee

This proposal focuses on the potential role of LD-RT, i.e. radiotherapy dosed at 6 Gy in the treatment of OA. Primary Objective: To assess the effect of low dose radiotherapy on pain and functioning in hand and knee osteoarthritis.Secondary…

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy

The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic…

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

1. To compare the efficacy of tofacitinib, in doses of 2 mg, 5 mg, and 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.2. To estimate the placebo-…

Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis

To evaluate the efficacy and safety of nilotinib in spondyloarthritis

Prevention of the progression of very early symptoms into ankylosing spondylitis

The general aim of this project is the primary prevention of the development of AS in patients with IBP, additional (SpA) features and inflammation on MRI of the SI joint and/or spine (but still no sacroiliitis on X-ray) by giving them, a short…

A multi-centre randomised double blind, placebo and active controlled parallel group study to investigate efficacy and safety of ONO-5334 in post menopausal women with osteopenia or osteoporosis.

The objective of this study is to investigate if use of ONO-5334 has a more positive effect on bone density and biochemical markers of bone turnover than Alendronate (a bisphosphonate) and placebo.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain

Primary ObjectivesThe primary objectives of this study are to evaluate the analgesic effect size over 12 weeks of several doses and dosage regimens of JNJ-42160443 compared with placebo in subjects with moderate to severe, chronic, low back pain (…

A randomized, single-blind, placebo controlled, parallel-group study evaluating the anti-inflamatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis (OSM105196)

Primary ObjectivesTo assess the change in inflammatory biomarkers in the synovial tissue of subjects with RA on a background of methotrexate after administration of a single, intravenous dose of GSK315234, as compared to placebo. To assess the…

ANTI-IGE THERAPY (OMALIZUMAB)
IN IGE-ACPA POSITIVE RHEUMATOID ARTHRITIS
Addendum: An open label extension study to provide continuation of anti-IgE therapy to Rheumatoid Arthritis patients who participated in the TIGER study P10.161

- To evaluate the safety and efficacy of anti-IgE therapy with respect to:Clinical disease activity (DAS44), laboratory parameters and adverse events. - To evaluate whether disease activity correlates with immunological parameters, including…