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
Results First Received: January 9, 2014  
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
Condition: Axial Spondyloarthritis
Interventions: Drug: etanercept
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Out of 128 screened participants, 90 were assigned to either double-blind etanercept (ETN) 50 mg to open-label ETN 50 mg or placebo to open-label ETN 50 mg group. Participants entered an escape arm at Week 4 visit if the total back pain or the BASDAI score increased >50% vs baseline or participants were with maximum tolerated NSAIDs.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four participants who were randomized to receive placebo in the double-blind phase were withdrawn during this phase, and they did not enter the escape arm, so these four participants never received ETN.

Reporting Groups
  Description
Double Blind ETN 50 mg to Open Label ETN 50 mg Group Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
Placebo to Open Label ETN 50 mg Group Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks

Participant Flow:   Overall Study
    Double Blind ETN 50 mg to Open Label ETN 50 mg Group     Placebo to Open Label ETN 50 mg Group  
STARTED     42     48  
COMPLETED     33     41  
NOT COMPLETED     9     7  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 2                 0  
Protocol Violation                 1                 1  
Adverse Event                 4                 3  
Does not meet entrance criteria                 0                 1  
Not specified                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Double Blind ETN 50 mg to Open Label ETN 50 mg Group Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
Placebo to Open Label ETN 50 mg Group Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Double Blind ETN 50 mg to Open Label ETN 50 mg Group     Placebo to Open Label ETN 50 mg Group     Total  
Number of Participants  
[units: participants]
  42     48     90  
Age, Customized  
[units: Participants]
     
18 - 44 Years     31     32     63  
45 - 64 Years     9     15     24  
≥ 65 Years     2     1     3  
Gender  
[units: Participants]
     
Female     18     16     34  
Male     24     32     56  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.   [ Time Frame: Week 8 ]

3.  Secondary:   Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.   [ Time Frame: Week 4 ]

4.  Secondary:   Change From Baseline in BASDAI at Week 8   [ Time Frame: Week 8 ]

5.  Secondary:   Change From Baseline in BASDAI Score at Weeks 12 and 16.   [ Time Frame: Week 12 and 16 ]

6.  Secondary:   Number of Participants Using NSAIDs at Week 8.   [ Time Frame: Week 8 ]

7.  Secondary:   Change From Baseline in Mini BASDAI at Week 8 (AUC).   [ Time Frame: Week 8 ]

8.  Secondary:   Number of Participants Achieved BASDAI 50 at Week 8.   [ Time Frame: Week 8 ]

9.  Secondary:   Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.   [ Time Frame: Weeks 4, 12 and 16 ]

10.  Secondary:   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 ]

11.  Secondary:   Number of Participants Achieving ASAS 20 at Week 8   [ Time Frame: Week 8 ]

12.  Secondary:   Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.   [ Time Frame: Weeks 4, 12 and 16 ]

13.  Secondary:   Number of Participants Achieving ASAS 40 at Week 8   [ Time Frame: Week 8 ]

14.  Secondary:   Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.   [ Time Frame: Weeks 4, 12 and 16 ]

15.  Secondary:   Number of Participants Achieving ASAS 70 at Week 8   [ Time Frame: Week 8 ]

16.  Secondary:   Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.   [ Time Frame: Week 4 ]

17.  Secondary:   Change From Baseline in ASDAS CRP Score at Week 8.   [ Time Frame: Week 8 ]

18.  Secondary:   Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.   [ Time Frame: Weeks 12 and 16 ]

19.  Secondary:   Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.   [ Time Frame: Week 4 ]

20.  Secondary:   Change From Baseline in ASDAS ESR Score at Week 8.   [ Time Frame: Week 8 ]

21.  Secondary:   Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.   [ Time Frame: Weeks 12 and 16 ]

22.  Secondary:   Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)   [ Time Frame: Week 16 ]

23.  Secondary:   Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)   [ Time Frame: Week 16 ]

24.  Secondary:   Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8   [ Time Frame: Week 8 ]

25.  Other Pre-specified:   Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4   [ Time Frame: Week 4 ]

26.  Other Pre-specified:   Change From Baseline in BAS-G Score at Week 8   [ Time Frame: Week 8 ]

27.  Other Pre-specified:   Change From Baseline in BAS-G Score at Weeks 12 and 16.   [ Time Frame: Weeks 12 and 16 ]

28.  Other Pre-specified:   Change From Baseline in Total Back Pain at Week 4   [ Time Frame: Week 4 ]

29.  Other Pre-specified:   Change From Baseline in Total Back Pain at Week 8   [ Time Frame: Week 8 ]

30.  Other Pre-specified:   Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16   [ Time Frame: Weeks 4, 8, 12 and 16 ]

31.  Other Pre-specified:   Change From Baseline in Nocturnal Back Pain at Week 4   [ Time Frame: Week 4 ]

32.  Other Pre-specified:   Change From Baseline in Nocturnal Back Pain at Week 8   [ Time Frame: Week 8 ]

33.  Other Pre-specified:   Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16   [ Time Frame: Weeks 12 and 16 ]

34.  Other Pre-specified:   Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4   [ Time Frame: Week 4 ]

35.  Other Pre-specified:   Change From Baseline in BASFI at Week 8   [ Time Frame: Week 8 ]

36.  Other Pre-specified:   Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4   [ Time Frame: Week 4 ]

37.  Other Pre-specified:   Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16   [ Time Frame: Weeks 12 and 16 ]

38.  Other Pre-specified:   Change From Baseline in PGA (Physician Global Assessment) at Week 4   [ Time Frame: Week 4 ]

39.  Other Pre-specified:   Change From Baseline in PGA (Physician Global Assessment) at Week 8   [ Time Frame: Week 8 ]

40.  Other Pre-specified:   Change From Baseline in PGA at Weeks 12 and 16   [ Time Frame: Weeks 12 and 16 ]

41.  Other Pre-specified:   Change From Baseline in Each BASFI Component at Week 4   [ Time Frame: Week 4 ]

42.  Other Pre-specified:   Change From Baseline in Each BASFI Component at Week 8   [ Time Frame: Week 8 ]

43.  Other Pre-specified:   Change From Baseline in Each BASFI Component at Week 12   [ Time Frame: Week 12 ]

44.  Other Pre-specified:   Change From Baseline in Each BASFI Component at Week 16   [ Time Frame: Week 16 ]

45.  Other Pre-specified:   Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16   [ Time Frame: Weeks 4, 8, 12 and 16 ]

46.  Other Pre-specified:   Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16   [ Time Frame: Weeks 4, 8, 12 and 16 ]

47.  Other Pre-specified:   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 ]

48.  Other Pre-specified:   Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8   [ Time Frame: Week 8 ]

49.  Other Pre-specified:   Number of Participants With MCII at Weeks 4, 12 and 16   [ Time Frame: Weeks 4, 12 and 16 ]

50.  Other Pre-specified:   Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16   [ Time Frame: Weeks 4, 8, 12 and 16 ]

51.  Other Pre-specified:   Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8   [ Time Frame: Week 8 ]

52.  Other Pre-specified:   Number of Participants With PASS at Weeks 4, 12 and 16   [ Time Frame: Weeks 4, 12 and 16 ]

53.  Other Pre-specified:   Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4   [ Time Frame: Week 4 ]

54.  Other Pre-specified:   Change From Baseline in BASMI at Week 8   [ Time Frame: Week 8 ]

55.  Other Pre-specified:   Change From Baseline in BASMI at Weeks 12 and 16   [ Time Frame: Weeks 12 and 16 ]

56.  Other Pre-specified:   Change From Baseline in BASMI Components at Week 4   [ Time Frame: Week 4 ]

57.  Other Pre-specified:   Change From Baseline in BASMI Components at Week 8   [ Time Frame: Week 8 ]

58.  Other Pre-specified:   Change From Baseline in BASMI Components at Week 12   [ Time Frame: Week 12 ]

59.  Other Pre-specified:   Change From Baseline in BASMI Components at Week 16   [ Time Frame: Week 16 ]

60.  Other Pre-specified:   Change From Baseline in Chest Expansion at Week 4   [ Time Frame: Week 4 ]

61.  Other Pre-specified:   Change From Baseline in Chest Expansion at Week 8   [ Time Frame: Week 8 ]

62.  Other Pre-specified:   Change From Baseline in Chest Expansion at Weeks 12 and 16   [ Time Frame: Weeks 12 and 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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