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

NCT01298531 | Completed Phase 4 Results

• 2 other identifiers: B18011320881A1-4749
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Axial Spondyloarthritis

Keywords

Etanercept; Axial Spondyloarthritis; NSAIDs sparing effect

Outcome Measures

Primary Outcomes (1)

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

  Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.

  Week 8

Secondary Outcomes (23)

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

  Week 8

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

  Week 4

• Change From Baseline in BASDAI at Week 8

  Week 8

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

  Week 12 and 16

• Number of Participants Using NSAIDs at Week 8.

  Week 8

Other Outcomes (38)

• Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4

  Week 4

• Change From Baseline in BAS-G Score at Week 8

  Week 8

• Change From Baseline in BAS-G Score at Weeks 12 and 16.

  Weeks 12 and 16

Study Arms (2)

etanercept

ACTIVE COMPARATOR

Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.

Drug: etanercept

etanercept-placebo

PLACEBO COMPARATOR

Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.

Drug: etanercept; Drug: placebo

Interventions

etanercept DRUG

etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.

Also known as: Enbrel

etanercept

placebo DRUG

placebo subcutaneous (SC) injections once weekly for 8 weeks.

etanercept-placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Institut Calot - Fondation Hopale

Berck, France, 62608, France

Location

Hopital Pellegrin

Bordeaux, 33076, France

Location

Centre Hospitalier, Service de Rhumatologie

Cahors, 46000, France

Location

CHU Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Hopital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

CH Le Mans

Le Mans, 72037, France

Location

Chu Dupuytren, Rhumatologie et Therapeutique

Limoges, 87042, France

Location

CHU Lapeyronie, Immuno-Rhumatologie

Montpellier, 34000, France

Location

Hopital de l'Archet

Nice, 06202, France

Location

Hopital Porte Madeleine

Orléans, 45032, France

Location

H�al Saint-Antoine

Paris, 75012, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Saint Joseph - Service de Rhumatologie

Paris, 75014, France

Location

Hopital Bichat

Paris, 75018, France

Location

Service de Rhumatologie

Paris, 75651 Cedex 13, France

Location

CHU Bois Guillaume - Service de Rhumatologie

Rouen, 76031, France

Location

CHU de Saint Etienne, Hopital Nord

Saint-Etienne, 42055, France

Location

Hopital Purpan

Toulouse, 31059, France

Location

Related Publications (2)

• 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.

  PMID: 26568588 DERIVED

• 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.

  PMID: 25428762 DERIVED

Related Links

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

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 17, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 29, 2014
• Results First Posted: July 29, 2014

Record last verified: 2014-07

Locations

FR (19)