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A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Axial Spondyloarthritis

Intervention: etanercept (Drug); etanercept (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.

Secondary outcome:

Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.

Change From Baseline in BASDAI at Week 8

Change From Baseline in BASDAI Score at Weeks 12 and 16.

Number of Participants Using NSAIDs at Week 8.

Change From Baseline in Mini BASDAI at Week 8 (AUC).

Number of Participants Achieved BASDAI 50 at Week 8.

Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.

Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16

Number of Participants Achieving ASAS 20 at Week 8

Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.

Number of Participants Achieving ASAS 40 at Week 8

Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.

Number of Participants Achieving ASAS 70 at Week 8

Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.

Change From Baseline in ASDAS CRP Score at Week 8.

Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.

Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.

Change From Baseline in ASDAS ESR Score at Week 8.

Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.

Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)

Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)

Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Institut Calot - Fondation Hopale, Berck-sur-Mer 62608, France

Hopital Pellegrin, Bordeaux Cedex 33076, France

Centre Hospitalier, Service de Rhumatologie, Cahors 46000, France

CHU Hopital Gabriel Montpied, Clermont-Ferrand 63003, France

Centre Hospitalier Sud Francilien, Corbeil Essonnes 91100, France

Hopital Bicetre, LE KREMLIN-BICETRE Cedex 94275, France

CH Le Mans, Le Mans 72037, France

Chu Dupuytren, Rhumatologie et Therapeutique, Limoges 87042, France

CHU Lapeyronie, Immuno-Rhumatologie, Montpellier 34000, France

Hopital de l'Archet, Nice 06202, France

Hopital Porte Madeleine, Orleans Cedex 1 45032, France

Hopital Bichat, Paris 75018, France

Hopital Cochin, Paris 75014, France

Hopital Saint Joseph - Service de Rhumatologie, Paris 75014, France

H�al Saint-Antoine, Paris 75012, France

Service de Rhumatologie, Paris 75651 Cedex 13, France

CHU Bois Guillaume - Service de Rhumatologie, Rouen 76031, France

CHU de Saint Etienne, Hopital Nord, Saint Etienne Cedex 2 42055, France

Hopital Purpan, Toulouse Cedex 09 31059, France

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2011
Last updated: July 28, 2014

Page last updated: August 20, 2015

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