A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis (SPARSE)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298531
First received: February 16, 2011
Last updated: April 16, 2013
Last verified: April 2013
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Purpose
This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Axial Spondyloarthritis |
Drug: etanercept Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi Centre, Double Blind, Placebo-controlled Study to Evaluate the Non Steroidal Anti-inflamatory Drugs (NSAIDS) Sparing Effect of Etanercept in Adult Subjects With Axial Involvement of Spondyloarthritis |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To compare the NSAID sparing effect of etanercept with that of placebo in adult subjects with axial involvement of SpA after 8 weeks of active treatment in comparison to Baseline (NSAID ASAS score). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The area under the curve (AUC) between randomization and Week 8 for the NSAID ASAS score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- The efficacy of etanercept for symptom control compared with that of placebo at Weeks 4 and 8. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- The change in concomitant NSAID treatment requirement between Baseline and Week 16 in the group originally receiving etanercept. [ Time Frame: 16weeks ] [ Designated as safety issue: No ]
- The change in concomitant NSAID treatment requirement between Week 8 and Week 16 in the group originally receiving placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- The efficacy of etanercept in the group receiving etanercept from Baseline up to Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- The change in efficacy in the group originally receiving placebo group from Week 8 to Week 16 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- The safety and tolerability of etanercept in this subject population [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 100 |
| Study Start Date: | May 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: etanercept
Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
|
Drug: etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
Other Name: Enbrel
|
|
Placebo Comparator: etanercept-placebo
Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
|
Drug: etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.
Other Name: Enbrel
Drug: placebo
placebo subcutaneous (SC) injections once weekly for 8 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects aged 18 years and over at the time of consent to the study.
- 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 are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298531
Locations
| France | |
| Institut Calot - Fondation Hopale | |
| Berck-sur-Mer, France, 62608 | |
| Hopital Pellegrin | |
| Bordeaux Cedex, France, 33076 | |
| Centre Hospitalier, Service de Rhumatologie | |
| Cahors, France, 46000 | |
| CHU Hopital Gabriel Montpied | |
| Clermont-Ferrand, France, 63003 | |
| Centre Hospitalier Sud Francilien | |
| Corbeil Essonnes, France, 91100 | |
| Hopital Bicetre | |
| LE KREMLIN-BICETRE Cedex, France, 94275 | |
| CH Le Mans | |
| Le Mans, France, 72037 | |
| Chu Dupuytren, Rhumatologie et Therapeutique | |
| Limoges, France, 87042 | |
| CHU Lapeyronie, Immuno-Rhumatologie | |
| Montpellier, France, 34000 | |
| Hopital de l'Archet | |
| Nice, France, 06202 | |
| Hopital Porte Madeleine | |
| Orleans Cedex 1, France, 45032 | |
| Hopital Saint Joseph - Service de Rhumatologie | |
| Paris, France, 75014 | |
| H�al Saint-Antoine | |
| Paris, France, 75012 | |
| Hopital Bichat | |
| Paris, France, 75018 | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| Service de Rhumatologie | |
| Paris, France, 75651 Cedex 13 | |
| CHU Bois Guillaume - Service de Rhumatologie | |
| Rouen, France, 76031 | |
| CHU de Saint Etienne, Hopital Nord | |
| Saint Etienne Cedex 2, France, 42055 | |
| Hopital Purpan | |
| Toulouse Cedex 09, France, 31059 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01298531 History of Changes |
| Other Study ID Numbers: | B1801132, 0881A1-4749 |
| Study First Received: | February 16, 2011 |
| Last Updated: | April 16, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee |
Keywords provided by Pfizer:
|
Etanercept Axial Spondyloarthritis NSAIDs sparing effect |
Additional relevant MeSH terms:
|
Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Musculoskeletal Diseases Arthritis Joint Diseases Bone Diseases, Infectious Infection Anti-Inflammatory Agents, Non-Steroidal TNFR-Fc fusion protein Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013