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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298531
First received: February 16, 2011
Last updated: July 28, 2014
Last verified: July 2014
  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:
  • Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 12 and 16 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Participants who received NSAIDs at Week 8 were reported.

  • Change From Baseline in Mini BASDAI at Week 8 (AUC). [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Weeks 4, 12 and 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 4, 12 and 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Weeks 4, 12 and 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Weeks 4, 12 and 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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. [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]

    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. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    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. [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BAS-G Score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BAS-G Score at Weeks 12 and 16. [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Total Back Pain at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Total Back Pain at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Nocturnal Back Pain at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Nocturnal Back Pain at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASFI at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in PGA (Physician Global Assessment) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

  • Change From Baseline in PGA (Physician Global Assessment) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

  • Change From Baseline in PGA at Weeks 12 and 16 [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]
    Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

  • Change From Baseline in Each BASFI Component at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Each BASFI Component at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Each BASFI Component at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Each BASFI Component at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.

  • Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.

  • Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With MCII at Weeks 4, 12 and 16 [ Time Frame: Weeks 4, 12 and 16 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 [ Time Frame: Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With PASS at Weeks 4, 12 and 16 [ Time Frame: Weeks 4, 12 and 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASMI at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASMI at Weeks 12 and 16 [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASMI Components at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASMI Components at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASMI Components at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BASMI Components at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Chest Expansion at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Chest Expansion at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Chest Expansion at Weeks 12 and 16 [ Time Frame: Weeks 12 and 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Service de Rhumatologie
Paris, France, 75651 Cedex 13
Hopital Cochin
Paris, France, 75014
Hopital Bichat
Paris, France, 75018
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
Results First Received: January 9, 2014
Last Updated: July 28, 2014
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
TNFR-Fc fusion protein
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
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 October 19, 2014