A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
NCT ID: NCT01298531
Last Updated: 2014-07-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2011-05-31
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes
NCT01258738
Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
NCT00420238
Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
NCT00544557
Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
NCT00458185
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
NCT01578850
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
etanercept
Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
etanercept-placebo
Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.
placebo
placebo subcutaneous (SC) injections once weekly for 8 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.
placebo
placebo subcutaneous (SC) injections once weekly for 8 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
* Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of \> 1 month (for both NSAIDs combined) before the Screening visit.
* Active axial involvement defined by mini BASDAI
Exclusion Criteria
* Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents.
* Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Calot - Fondation Hopale
Berck, France, France
Hopital Pellegrin
Bordeaux, , France
Centre Hospitalier, Service de Rhumatologie
Cahors, , France
CHU Hopital Gabriel Montpied
Clermont-Ferrand, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
Hopital Bicetre
Le Kremlin-Bicêtre, , France
CH Le Mans
Le Mans, , France
Chu Dupuytren, Rhumatologie et Therapeutique
Limoges, , France
CHU Lapeyronie, Immuno-Rhumatologie
Montpellier, , France
Hopital de l'Archet
Nice, , France
Hopital Porte Madeleine
Orléans, , France
H�al Saint-Antoine
Paris, , France
Hopital Cochin
Paris, , France
Hopital Saint Joseph - Service de Rhumatologie
Paris, , France
Hopital Bichat
Paris, , France
Service de Rhumatologie
Paris, , France
CHU Bois Guillaume - Service de Rhumatologie
Rouen, , France
CHU de Saint Etienne, Hopital Nord
Saint-Etienne, , France
Hopital Purpan
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dougados M, Wood E, Gossec L, Dubanchet A, Logeart I, van der Heijde D. Discriminant Capacity of Clinical Efficacy and Nonsteroidal Antiinflammatory Drug-sparing Endpoints, Alone or in Combination, in Axial Spondyloarthritis. J Rheumatol. 2015 Dec;42(12):2361-8. doi: 10.3899/jrheum.150378. Epub 2015 Nov 15.
Dougados M, Wood E, Combe B, Schaeverbeke T, Miceli-Richard C, Berenbaum F, Koppiker N, Dubanchet A, Logeart I. Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study. Arthritis Res Ther. 2014 Nov 27;16(6):481. doi: 10.1186/s13075-014-0481-5.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0881A1-4749
Identifier Type: -
Identifier Source: secondary_id
B1801132
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.