Trial Outcomes & Findings for Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis (NCT NCT00247962)
NCT ID: NCT00247962
Last Updated: 2012-11-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
566 participants
Primary outcome timeframe
16 weeks
Results posted on
2012-11-08
Participant Flow
Subjects were recruited in multiple countries from December 2005 to September 2007.
Subjects were screened up to 4 weeks in a 2:1 randomization ratio.
Participant milestones
| Measure |
Etanercept
etanercept 50 mg once weekly
|
Sulphasalazine
Sulphasalazine (SSZ) titration up to 3 g daily
|
|---|---|---|
|
Overall Study
STARTED
|
379
|
187
|
|
Overall Study
COMPLETED
|
353
|
168
|
|
Overall Study
NOT COMPLETED
|
26
|
19
|
Reasons for withdrawal
| Measure |
Etanercept
etanercept 50 mg once weekly
|
Sulphasalazine
Sulphasalazine (SSZ) titration up to 3 g daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
12
|
|
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
|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
Baseline Characteristics
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Etanercept
n=379 Participants
etanercept 50 mg once weekly
|
Sulphasalazine
n=187 Participants
Sulphasalazine (SSZ) titration up to 3 g daily
|
Total
n=566 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.69 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
40.90 years
STANDARD_DEVIATION 12.23 • n=7 Participants
|
40.76 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
279 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
419 Participants
n=5 Participants
|
|
Region of Enrollment
Qatar
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
11 participants
n=5 Participants
|
3 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
19 participants
n=5 Participants
|
8 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
38 participants
n=5 Participants
|
19 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
36 participants
n=5 Participants
|
18 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
27 participants
n=5 Participants
|
15 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
30 participants
n=5 Participants
|
15 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
62 participants
n=5 Participants
|
31 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Region of Enrollment
China
|
17 participants
n=5 Participants
|
9 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
54 participants
n=5 Participants
|
27 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Etanercept
n=378 Participants
etanercept 50 mg once weekly
|
Sulphasalazine
n=187 Participants
Sulphasalazine (SSZ) titration up to 3 g daily
|
|---|---|---|
|
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
|
287 participants
|
99 participants
|
SECONDARY outcome
Timeframe: Baseline and 16 WeeksPopulation: The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.
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).
Outcome measures
| Measure |
Etanercept
n=76 Participants
etanercept 50 mg once weekly
|
Sulphasalazine
n=34 Participants
Sulphasalazine (SSZ) titration up to 3 g daily
|
|---|---|---|
|
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
Baseline
|
11.03 units on a scale
Standard Deviation 4.60
|
11.32 units on a scale
Standard Deviation 4.75
|
|
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
Week 16
|
6.21 units on a scale
Standard Deviation 5.31
|
9.06 units on a scale
Standard Deviation 5.68
|
Adverse Events
Etanercept
Serious events: 7 serious events
Other events: 213 other events
Deaths: 0 deaths
Sulphasalazine
Serious events: 4 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
etanercept 50 mg once weekly
|
Sulphasalazine
Sulphasalazine (SSZ) titration up to 3 g daily
|
|---|---|---|
|
General disorders
Abdominal Pain
|
0.00%
0/379
|
0.53%
1/187
|
|
General disorders
Accidental Injury
|
0.00%
0/379
|
0.53%
1/187
|
|
Vascular disorders
Migraine
|
0.26%
1/379
|
0.00%
0/187
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.26%
1/379
|
0.00%
0/187
|
|
Gastrointestinal disorders
Colitis
|
0.26%
1/379
|
0.00%
0/187
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/379
|
0.53%
1/187
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.26%
1/379
|
0.00%
0/187
|
|
Nervous system disorders
Dizziness
|
0.00%
0/379
|
0.53%
1/187
|
|
Nervous system disorders
Hypesthesia
|
0.26%
1/379
|
0.00%
0/187
|
|
Nervous system disorders
Neuralgia
|
0.26%
1/379
|
0.00%
0/187
|
|
Nervous system disorders
Paresis
|
0.26%
1/379
|
0.00%
0/187
|
|
Nervous system disorders
Psychosis
|
0.00%
0/379
|
0.53%
1/187
|
|
Nervous system disorders
Ptosis
|
0.26%
1/379
|
0.00%
0/187
|
|
Nervous system disorders
Vertigo
|
0.26%
1/379
|
0.00%
0/187
|
Other adverse events
| Measure |
Etanercept
etanercept 50 mg once weekly
|
Sulphasalazine
Sulphasalazine (SSZ) titration up to 3 g daily
|
|---|---|---|
|
General disorders
Headache
|
7.7%
29/379
|
11.2%
21/187
|
|
General disorders
Injection Site Reaction
|
10.8%
41/379
|
1.6%
3/187
|
|
Vascular disorders
Cardiovascular
|
6.1%
23/379
|
5.3%
10/187
|
|
Gastrointestinal disorders
Nausea
|
6.6%
25/379
|
9.6%
18/187
|
|
Metabolism and nutrition disorders
Metabolic and Nutritional
|
6.3%
24/379
|
2.7%
5/187
|
|
Nervous system disorders
Nervous
|
6.3%
24/379
|
10.2%
19/187
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
8.2%
31/379
|
9.1%
17/187
|
|
Skin and subcutaneous tissue disorders
Skin and appendages
|
10.3%
39/379
|
7.5%
14/187
|
|
Eye disorders
Special Senses
|
6.6%
25/379
|
7.0%
13/187
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER