Clinical trials: Spine Disease
Intervertebral Disc Degeneration
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- Trial name
- MASTERS-D2 (NCT02617563)
- Testing
- Minimally invasive lumbar fusion
- Where
- 27 sites in Argentina, Austria and 15 more
- Volunteers
- 361 people
- Sponsor
- Medtronic Spinal and Biologics
Spondylitis, Ankylosing
Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)
This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to evaluate the efficacy of infliximab 3 mg/kg.
- Trial name
- CANDLE (NCT00202865)
- Testing
- infliximab
- Volunteers
- 76 people
- Sponsor
- Merck Sharp & Dohme LLC
Arthritis, Psoriatic
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha…
- Trial name
- AFFINITY (NCT05071664)
- Testing
- Guselkumab, Golimumab
- Where
- 82 sites in United States, Denmark and 8 more
- Volunteers
- 91 people
- Sponsor
- Janssen Research & Development, LLC
Degenerative Disc Disease
A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease
SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance.
- Trial name
- NCT03246399
- Testing
- SM04690
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Biosplice Therapeutics, Inc.
Arthritis, Psoriatic
Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.
- Trial name
- NCT00367237
- Testing
- Infliximab + methotrexate (IFX + MTX), Methotrexate (MTX)
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Psoriatic Arthritis
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the…
- Trial name
- CONTROL (NCT02814175)
- Testing
- methotrexate (MTX), adalimumab (ADA)
- Where
- 60 sites in United States, Australia and 12 more
- Volunteers
- 246 people
- Sponsor
- AbbVie
Ankylosing Spondylitis
An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1
This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess the long-term efficacy and safety of multiple…
- Trial name
- NCT01571206
- Testing
- Infliximab
- Where
- South Korea
- Volunteers
- 174 people
- Sponsor
- Celltrion
Ankylosing Spondylitis
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.
- Trial name
- NCT03502616
- Testing
- Tofacitinib
- Where
- 99 sites in United States, Australia and 12 more
- Volunteers
- 270 people
- Sponsor
- Pfizer
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Psoriatic Arthritis
A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
- Trial name
- BE ACTIVE (NCT02969525)
- Testing
- Bimekizumab
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 206 people
- Sponsor
- UCB Biopharma S.P.R.L.
Ankylosing Spondylitis
Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are…
- Trial name
- ATLAS (NCT00085644)
- Testing
- adalimumab (D2E7)
- Where
- 22 sites in United States
- Volunteers
- 315 people
- Sponsor
- Abbott
Arthritis, Psoriatic
A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
This is a multicenter, prospective, non-interventional, observational single arm study. 100 patients will be recruited in the Netherlands over a one year period.
- Trial name
- REWARD (NCT02875184)
- Where
- 21 sites in Netherlands
- Volunteers
- 200 people
- Sponsor
- Amgen
Idiopathic Scoliosis, Spinal Curvatures
UNiD Rods Register
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety
- Conditions
- Idiopathic Scoliosis, Spinal Curvatures, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT02926404
- Testing
- UNiD Rods
- Where
- 13 sites in Belgium, France and 1 more
- Volunteers
- 743 people
- Sponsor
- Medicrea International
Degenerative Disc Disease, Spinal Stenosis
SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Scoliosis
- Trial name
- NCT04566874
- Testing
- ALIF
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Camber Spine Technologies
Arthritis, Psoriatic
Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis
The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.
- Trial name
- PROVE (NCT00938015)
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 303 people
- Sponsor
- Pfizer
Lumbar Spinal Stenosis
Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal…
- Trial name
- NCT00529997
- Testing
- Stabilimax NZ® Dynamic Spine Stabilization System
- Where
- 19 sites in United States
- Volunteers
- 480 people
- Sponsor
- Applied Spine Technologies
Spinal Stenosis, Spondylolisthesis
RAMP Study: A Study Comparing Two Lumbar Fusion Procedures
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format.
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- RAMP (NCT01716182)
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Baxano Surgical, Inc.
Degenerative Disc Disease
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
- Trial name
- NCT01124006
- Testing
- Intradiscal rhGDF-5, Water for injection
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- DePuy Spine
Crohn Disease, Ulcerative Colitis
SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Trial name
- SAPHIR (NCT05598684)
- Where
- 96 sites in France, Guadeloupe and 1 more
- Volunteers
- 600 people
- Sponsor
- Fresenius Kabi, France
Degenerative Disc Disease
A Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® Device using laparoscopic surgical technique as compared to an historical control group treated with Autogenous Bone/LT-CAGE® Device using…
- Trial name
- NCT01491425
- Testing
- rhBMP-2/ACS//LT-CAGE® Device, Autogenous Bone//LT-CAGE® Device
- Volunteers
- 134 people
- Sponsor
- Medtronic Spinal and Biologics