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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00410046




Registration number
NCT00410046
Ethics application status
Date submitted
8/12/2006
Date registered
12/12/2006
Date last updated
11/05/2012

Titles & IDs
Public title
Extension Study Evaluating Etanercept in Ankylosing Spondylitis
Scientific title
An Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing Spondylitis
Secondary ID [1] 0 0
0881A3-405
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enbrel (etanercept)

Experimental: Etanercept (ETN) - Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.


Treatment: Drugs: Enbrel (etanercept)
Etanercept 50 mg SC injection once weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
Timepoint [1] 0 0
96 weeks
Primary outcome [2] 0 0
Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
Timepoint [2] 0 0
96 weeks
Secondary outcome [1] 0 0
Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Number of Patients With Sick Leave During 48 Weeks Treatment
Timepoint [3] 0 0
48 weeks
Secondary outcome [4] 0 0
Number of Sick Days Per Patient During the 48 Weeks of Treatment
Timepoint [4] 0 0
48 weeks
Secondary outcome [5] 0 0
Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
Timepoint [5] 0 0
Baseline and 38 weeks
Secondary outcome [6] 0 0
Change in Total Back Pain Score From Baseline to Week 38
Timepoint [6] 0 0
Baseline and 38 weeks
Secondary outcome [7] 0 0
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38
Timepoint [7] 0 0
Baseline and 38 weeks
Secondary outcome [8] 0 0
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
Timepoint [8] 0 0
Baseline and 38 weeks
Secondary outcome [9] 0 0
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38
Timepoint [9] 0 0
Baseline and 38 weeks
Secondary outcome [10] 0 0
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38
Timepoint [10] 0 0
Baseline and 38 weeks
Secondary outcome [11] 0 0
Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38
Timepoint [11] 0 0
Baseline and 38 weeks
Secondary outcome [12] 0 0
Change From Baseline Haywood Quality of Life Score From Baseline to Week 38
Timepoint [12] 0 0
Baseline and 38 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

* Patients who completed 16 weeks of treatment and have completed the baseline health care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Withdrawal from the ASCEND study for safety or any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Fredriksberg
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
Denmark
State/province [3] 0 0
Svendborg
Country [4] 0 0
Denmark
State/province [4] 0 0
Vejle
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
Finland
State/province [6] 0 0
Hyvinkaa
Country [7] 0 0
Finland
State/province [7] 0 0
Kuopio
Country [8] 0 0
Finland
State/province [8] 0 0
Tampere
Country [9] 0 0
Sweden
State/province [9] 0 0
Stockholm
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Basingstoke
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Bath
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Cambridge
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Cannock
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Liverpool
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Newcastle upon Tyne
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.
Trial website
https://clinicaltrials.gov/study/NCT00410046
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth Reserach
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00410046