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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
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00410046