Extension Study Evaluating Etanercept in Ankylosing Spondylitis

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00410046

First received: December 8, 2006

Last updated: April 9, 2012

Last verified: April 2012

History of Changes

Results First Received: October 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Ankylosing Spondylitis
Intervention:	Drug: Enbrel (etanercept)

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
Patients were recruited in Europe from November 2006 to January 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients in 0881A3-402 (NCT00247962) were randomized to receive etanercept (ETN) or sulphasalazine (SSZ). After completion, they were eligible for enrollment into this extension study and all patients received ETN. Outcome measure analysis kept the 0881A3-402 assignment of ETN or SSZ. This enabled an analysis of changes from the original baseline.

Reporting Groups

	Description
Etanercept	Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Participant Flow: Overall Study

	Etanercept
STARTED	84
COMPLETED	79
NOT COMPLETED	5
Adverse Event	3
Withdrawal by Subject	1
Lost to Follow-up	1

Baseline Characteristics

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Reporting Groups

	Description
Etanercept	Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Baseline Measures

	Etanercept
Number of Participants [units: participants]	84
Age [units: years] Mean ± Standard Deviation	42.70 ± 10.49
Gender [units: patients]
Female	13
Male	71

Outcome Measures

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1. Primary:

Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment [ Time Frame: 96 weeks ]

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2. Primary:

Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment [ Time Frame: 96 weeks ]

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3. Secondary:

Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment [ Time Frame: 48 weeks ]

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4. Secondary:

Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment [ Time Frame: 48 weeks ]

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5. Secondary:

Number of Patients With Sick Leave During 48 Weeks Treatment [ Time Frame: 48 weeks ]

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6. Secondary:

Number of Sick Days Per Patient During the 48 Weeks of Treatment [ Time Frame: 48 weeks ]

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7. Secondary:

Change in Patient Global Assessment of Disease Activity From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ]

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8. Secondary:

Change in Total Back Pain Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ]

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9. Secondary:

Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ]

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10. Secondary:

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ]

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Measure Type	Secondary
Measure Title	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
Measure Description	BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame	Baseline and 38 weeks
Safety Issue	No

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.
All patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment.

Reporting Groups

	Description
Etanercept / ETN	Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
SSZ / ETN	Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Measured Values

	Etanercept / ETN	SSZ / ETN
Number of Participants Analyzed [units: participants]	52	24
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38 [units: units on scale] Mean ± Standard Deviation	46.00 ± 31.45	31.13 ± 43.76

No statistical analysis provided for Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38

11. Secondary:

Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38 [ Time Frame: Baseline and 38 weeks ]

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12. Secondary:

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ]

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13. Secondary:

Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ]

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14. Secondary:

Change From Baseline Haywood Quality of Life Score From Baseline to Week 38 [ Time Frame: Baseline and 38 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00410046 History of Changes
Other Study ID Numbers:	0881A3-405
Study First Received:	December 8, 2006
Results First Received:	October 30, 2009
Last Updated:	April 9, 2012
Health Authority:	Denmark: National Board of Health

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