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A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis

PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active radiographic axial spondyloarthritis (rad-axSpA) at Week 16.SecondaryThe major…

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

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…

A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis

1) to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in DMARD naïve PsA patients2) to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in DMARD naïve PsA patients3) to…

Uncemented tibial component fixation in total knee replacement using porous titanium. A Randomized RSA Study

The aim of this study is to compare the early post-operative migration as measured by Roentgen Stereophotogrammetric Analysis (RSA) of the uncemented tibial component with plasma spray coating with the uncemented porous coated tibia component.

Intra-articular injection of stromal vascular fraction from adipose tissue in osteoartritis of the temporomandibular joint

The main objective is to objectify if the injection of SVF influences the pain of the TMJ during movement. Secondary objectives are pain during rest, maximum mouth opening, and function evaluation.

Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties and
safety of prednisolone in hand osteoarthritis: a proof-of-concept study

Primary Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.Secondary Objectives: The secondary…

A prospective randomised Rontgen Stereophotogrammatic Analysis (RSA) study using the uncemented Trident Tritanium acetabular component and the uncemented HA coated Symax hip stem in a single centre.
Assessment of implant migration, bone remodeling and clinical function.

The goal of this clinical investigation is to assess the early migration and bone remodeling of the Symax hip stem and the Trident HA coated or Trident Tritanium acetabulum component with RSA and 18-F PET CT Also the sensitivity of the RSA…

A Randomized Controlled Trial of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusions

The primary objective of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.

A multicenter, open-label (Part A) followed by a randomized, double-blind, parallel-group, placebo controlled study (Part B) to evaluate maintenance of remission in subjects with active axial spondyloarthritis (axSpA) receiving either Certolizumab pegol 200mg Q2W or 200mg Q4W as compared to placebo

The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients with Radiographic Axial Spondyloarthritis

PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W) versus placebo in patients with active rad-axSpA at Week 16.SecondaryThe major secondary objective is:To compare both ixekizumab regimens (80 mg Q2W or 80…

The anterior approach for THA:
A (cost-) effectiveness analysis compared to the posterolateral approach

To assess the clinical and cost effectiveness of the anterior approach, compared to the conventional posterolateral approach for THA in terms of physical functioning and health-related quality of life

Dorsal spondylodesis in adolescent idiopathic scoliosis: proximal fixation with screws versus claw construct

The main objective is to compare the coronal Cobb angle correction of proximal hook claw fixation versus proximal pedicle screw fixation after two years of follow-up. The secondary objectives of the study are: comparison of coronal Cobb angle…

A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long-term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis (CAIN457F2310)

Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNF*…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…

A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in autoinjectors, to demonstrate efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 3 years in subjects with active Psoriatic Arthritis (CAIN457F2318)

Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebo based on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- PASI75 week 24- PASI90 week 24-…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…

Efficacy of paracetamol and diclofenac for patients with acute low back pain: a randomized placebo controlled trial (PACE plus trial)

Based on the identified gaps in the evidence underlying the clinical guidelines on non-specific low back pain of the Dutch College of GPs and the recent findings of the Australian PACE study the objectives of the present study are: 1. What is the…

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

The effect of Hoffa*s fat pad resection in total knee arthroplasty on functionality and pain: a double blind, randomized clinical trial

The main objective of this study is to test if resection of Hoffa*s fat pad in total knee arthroplasty leads to a greater range of motion and if resection leads to a faster recovery of normal walking gait and preferred walking speed post operatively…