search
Back to results

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

Primary Purpose

Axial Spondyloarthritis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
etanercept
etanercept
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring Etanercept, Axial Spondyloarthritis, NSAIDs sparing effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Calot - Fondation Hopale
  • Hopital Pellegrin
  • Centre Hospitalier, Service de Rhumatologie
  • CHU Hopital Gabriel Montpied
  • Centre Hospitalier Sud Francilien
  • Hopital Bicetre
  • CH Le Mans
  • Chu Dupuytren, Rhumatologie et Therapeutique
  • CHU Lapeyronie, Immuno-Rhumatologie
  • Hopital de l'Archet
  • Hopital Porte Madeleine
  • H�al Saint-Antoine
  • Hopital Cochin
  • Hopital Saint Joseph - Service de Rhumatologie
  • Hopital Bichat
  • Service de Rhumatologie
  • CHU Bois Guillaume - Service de Rhumatologie
  • CHU de Saint Etienne, Hopital Nord
  • Hopital Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

etanercept

etanercept-placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.
The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Change From Baseline in BASDAI at Week 8
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Change From Baseline in BASDAI Score at Weeks 12 and 16.
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Number of Participants Using NSAIDs at Week 8.
Participants who received NSAIDs at Week 8 were reported.
Change From Baseline in Mini BASDAI at Week 8 (AUC).
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Number of Participants Achieved BASDAI 50 at Week 8.
Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.
Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.
Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.
Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Participants Achieving ASAS 20 at Week 8
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Participants Achieving ASAS 40 at Week 8
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Participants Achieving ASAS 70 at Week 8
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)
Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).
Change From Baseline in ASDAS CRP Score at Week 8.
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).
Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).
Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).
Change From Baseline in ASDAS ESR Score at Week 8.
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).
Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).
Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)
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.
Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)
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.
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8
Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.

Full Information

First Posted
February 16, 2011
Last Updated
July 28, 2014
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01298531
Brief Title
A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
Acronym
SPARSE
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
Etanercept, Axial Spondyloarthritis, NSAIDs sparing effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etanercept
Arm Type
Active Comparator
Arm Description
Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
Arm Title
etanercept-placebo
Arm Type
Placebo Comparator
Arm Description
Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
Intervention Type
Drug
Intervention Name(s)
etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo subcutaneous (SC) injections once weekly for 8 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.
Description
The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.
Time Frame
Week 8
Title
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.
Description
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time Frame
Week 4
Title
Change From Baseline in BASDAI at Week 8
Description
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time Frame
Week 8
Title
Change From Baseline in BASDAI Score at Weeks 12 and 16.
Description
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time Frame
Week 12 and 16
Title
Number of Participants Using NSAIDs at Week 8.
Description
Participants who received NSAIDs at Week 8 were reported.
Time Frame
Week 8
Title
Change From Baseline in Mini BASDAI at Week 8 (AUC).
Description
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time Frame
Week 8
Title
Number of Participants Achieved BASDAI 50 at Week 8.
Description
Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.
Time Frame
Week 8
Title
Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.
Description
Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.
Time Frame
Weeks 4, 12 and 16
Title
Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time Frame
Weeks 4, 12 and 16
Title
Number of Participants Achieving ASAS 20 at Week 8
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time Frame
Week 8
Title
Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time Frame
Weeks 4, 12 and 16
Title
Number of Participants Achieving ASAS 40 at Week 8
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time Frame
Week 8
Title
Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time Frame
Weeks 4, 12 and 16
Title
Number of Participants Achieving ASAS 70 at Week 8
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)
Time Frame
Week 8
Title
Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.
Description
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).
Time Frame
Week 4
Title
Change From Baseline in ASDAS CRP Score at Week 8.
Description
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).
Time Frame
Week 8
Title
Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.
Description
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).
Time Frame
Weeks 12 and 16
Title
Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.
Description
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).
Time Frame
Week 4
Title
Change From Baseline in ASDAS ESR Score at Week 8.
Description
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).
Time Frame
Week 8
Title
Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.
Description
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).
Time Frame
Weeks 12 and 16
Title
Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)
Description
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.
Time Frame
Week 16
Title
Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)
Description
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.
Time Frame
Week 16
Title
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8
Description
Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.
Time Frame
Week 8
Other Pre-specified Outcome Measures:
Title
Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4
Description
BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.
Time Frame
Week 4
Title
Change From Baseline in BAS-G Score at Week 8
Description
BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.
Time Frame
Week 8
Title
Change From Baseline in BAS-G Score at Weeks 12 and 16.
Description
BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.
Time Frame
Weeks 12 and 16
Title
Change From Baseline in Total Back Pain at Week 4
Description
Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time Frame
Week 4
Title
Change From Baseline in Total Back Pain at Week 8
Description
Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time Frame
Week 8
Title
Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16
Description
Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time Frame
Weeks 4, 8, 12 and 16
Title
Change From Baseline in Nocturnal Back Pain at Week 4
Description
Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time Frame
Week 4
Title
Change From Baseline in Nocturnal Back Pain at Week 8
Description
Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time Frame
Week 8
Title
Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16
Description
Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time Frame
Weeks 12 and 16
Title
Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4
Description
Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.
Time Frame
Week 4
Title
Change From Baseline in BASFI at Week 8
Description
Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.
Time Frame
Week 8
Title
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4
Description
Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.
Time Frame
Week 4
Title
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16
Description
Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.
Time Frame
Weeks 12 and 16
Title
Change From Baseline in PGA (Physician Global Assessment) at Week 4
Description
The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).
Time Frame
Week 4
Title
Change From Baseline in PGA (Physician Global Assessment) at Week 8
Description
Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).
Time Frame
Week 8
Title
Change From Baseline in PGA at Weeks 12 and 16
Description
Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).
Time Frame
Weeks 12 and 16
Title
Change From Baseline in Each BASFI Component at Week 4
Description
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time Frame
Week 4
Title
Change From Baseline in Each BASFI Component at Week 8
Description
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time Frame
Week 8
Title
Change From Baseline in Each BASFI Component at Week 12
Description
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time Frame
Week 12
Title
Change From Baseline in Each BASFI Component at Week 16
Description
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time Frame
Week 16
Title
Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16
Description
Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.
Time Frame
Weeks 4, 8, 12 and 16
Title
Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16
Description
Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.
Time Frame
Weeks 4, 8, 12 and 16
Title
Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16
Description
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).
Time Frame
Weeks 4, 8, 12 and 16
Title
Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8
Description
MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.
Time Frame
Week 8
Title
Number of Participants With MCII at Weeks 4, 12 and 16
Description
MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.
Time Frame
Weeks 4, 12 and 16
Title
Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16
Description
MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.
Time Frame
Weeks 4, 8, 12 and 16
Title
Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8
Description
PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.
Time Frame
Week 8
Title
Number of Participants With PASS at Weeks 4, 12 and 16
Description
PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.
Time Frame
Weeks 4, 12 and 16
Title
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4
Description
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time Frame
Week 4
Title
Change From Baseline in BASMI at Week 8
Description
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time Frame
Week 8
Title
Change From Baseline in BASMI at Weeks 12 and 16
Description
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time Frame
Weeks 12 and 16
Title
Change From Baseline in BASMI Components at Week 4
Description
BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time Frame
Week 4
Title
Change From Baseline in BASMI Components at Week 8
Description
BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time Frame
Week 8
Title
Change From Baseline in BASMI Components at Week 12
Description
BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time Frame
Week 12
Title
Change From Baseline in BASMI Components at Week 16
Description
BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time Frame
Week 16
Title
Change From Baseline in Chest Expansion at Week 4
Description
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time Frame
Week 4
Title
Change From Baseline in Chest Expansion at Week 8
Description
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time Frame
Week 8
Title
Change From Baseline in Chest Expansion at Weeks 12 and 16
Description
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time Frame
Weeks 12 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Institut Calot - Fondation Hopale
City
Berck-sur-Mer
ZIP/Postal Code
62608
Country
France
Facility Name
Hopital Pellegrin
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier, Service de Rhumatologie
City
Cahors
ZIP/Postal Code
46000
Country
France
Facility Name
CHU Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Hopital Bicetre
City
LE KREMLIN-BICETRE Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Chu Dupuytren, Rhumatologie et Therapeutique
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU Lapeyronie, Immuno-Rhumatologie
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Hopital de l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Porte Madeleine
City
Orleans Cedex 1
ZIP/Postal Code
45032
Country
France
Facility Name
H�al Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Saint Joseph - Service de Rhumatologie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Service de Rhumatologie
City
Paris
ZIP/Postal Code
75651 Cedex 13
Country
France
Facility Name
CHU Bois Guillaume - Service de Rhumatologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU de Saint Etienne, Hopital Nord
City
Saint Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Hopital Purpan
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26568588
Citation
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.
Results Reference
derived
PubMed Identifier
25428762
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801132&StudyName=A%20Study%20to%20Evaluate%20the%20NSAIDS%20Sparing%20Effect%20of%20Etanercept%20in%20Subjects%20with%20Axial%20Spondyloarthritis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs