Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Spondylitis (AS)
Brief summary
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Interventions
DRUGetanercept
50 mg
DRUGsulphasalazine (SSZ)
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ankylosing spondylitis * Active ankylosing spondylitis
Exclusion criteria
* Complete ankylosis of spine * Previous treatment with etanercept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) | 16 weeks | 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 improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | Baseline and 16 Weeks | ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a Yes (scored as 1) or No (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL). |
Countries
Australia, Austria, China, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Qatar, Saudi Arabia, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
Subjects were recruited in multiple countries from December 2005 to September 2007.
Pre-assignment details
Subjects were screened up to 4 weeks in a 2:1 randomization ratio.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept etanercept 50 mg once weekly | 379 |
| Sulphasalazine Sulphasalazine (SSZ) titration up to 3 g daily | 187 |
| Total | 566 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 12 |
| Overall Study | Lack of Efficacy | 4 | 2 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Etanercept | Sulphasalazine | Total |
|---|---|---|---|
| Age Continuous | 40.69 years STANDARD_DEVIATION 11.69 | 40.90 years STANDARD_DEVIATION 12.23 | 40.76 years STANDARD_DEVIATION 11.86 |
| Region of Enrollment Australia | 5 participants | 2 participants | 7 participants |
| Region of Enrollment Austria | 3 participants | 1 participants | 4 participants |
| Region of Enrollment China | 17 participants | 9 participants | 26 participants |
| Region of Enrollment Colombia | 8 participants | 4 participants | 12 participants |
| Region of Enrollment Czech Republic | 36 participants | 18 participants | 54 participants |
| Region of Enrollment Denmark | 13 participants | 6 participants | 19 participants |
| Region of Enrollment Finland | 11 participants | 3 participants | 14 participants |
| Region of Enrollment France | 4 participants | 1 participants | 5 participants |
| Region of Enrollment Germany | 62 participants | 31 participants | 93 participants |
| Region of Enrollment Greece | 4 participants | 3 participants | 7 participants |
| Region of Enrollment Hungary | 27 participants | 15 participants | 42 participants |
| Region of Enrollment Ireland | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Italy | 19 participants | 8 participants | 27 participants |
| Region of Enrollment Mexico | 11 participants | 6 participants | 17 participants |
| Region of Enrollment Netherlands | 7 participants | 4 participants | 11 participants |
| Region of Enrollment Poland | 30 participants | 15 participants | 45 participants |
| Region of Enrollment Portugal | 4 participants | 2 participants | 6 participants |
| Region of Enrollment Qatar | 7 participants | 3 participants | 10 participants |
| Region of Enrollment Serbia | 54 participants | 27 participants | 81 participants |
| Region of Enrollment Spain | 12 participants | 7 participants | 19 participants |
| Region of Enrollment Sweden | 4 participants | 2 participants | 6 participants |
| Region of Enrollment Switzerland | 2 participants | 1 participants | 3 participants |
| Region of Enrollment United Kingdom | 38 participants | 19 participants | 57 participants |
| Sex: Female, Male Female | 100 Participants | 47 Participants | 147 Participants |
| Sex: Female, Male Male | 279 Participants | 140 Participants | 419 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 213 / — | 100 / — |
| serious Total, serious adverse events | 7 / — | 4 / — |
Outcome results
Primary
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
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 improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time frame: 16 weeks
Population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) | 287 participants |
| Sulphasalazine | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) | 99 participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a Yes (scored as 1) or No (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).
Time frame: Baseline and 16 Weeks
Population: The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | Baseline | 11.03 units on a scale | Standard Deviation 4.6 |
| Etanercept | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | Week 16 | 6.21 units on a scale | Standard Deviation 5.31 |
| Sulphasalazine | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | Baseline | 11.32 units on a scale | Standard Deviation 4.75 |
| Sulphasalazine | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline | Week 16 | 9.06 units on a scale | Standard Deviation 5.68 |
Comparison: baselinep-value: 0.719ANCOVA
Comparison: week 16p-value: 0.01ANCOVA