Trial Outcomes & Findings for Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis (NCT NCT00900796)
NCT ID: NCT00900796
Last Updated: 2012-06-19
Results Overview
Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.
COMPLETED
132 participants
Week 16
2012-06-19
Participant Flow
Participant milestones
| Measure |
Anti-tumor Necrosis Factor Agents
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study.
|
|---|---|
|
Phase 1
STARTED
|
132
|
|
Phase 1
COMPLETED
|
121
|
|
Phase 1
NOT COMPLETED
|
11
|
|
Between Phase 1 and Phase 2
STARTED
|
121
|
|
Between Phase 1 and Phase 2
COMPLETED
|
11
|
|
Between Phase 1 and Phase 2
NOT COMPLETED
|
110
|
|
Phase 2
STARTED
|
11
|
|
Phase 2
COMPLETED
|
6
|
|
Phase 2
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Anti-tumor Necrosis Factor Agents
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study.
|
|---|---|
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Phase 1
Lacked sufficient information
|
4
|
|
Phase 1
Missing information at Week 16
|
7
|
|
Between Phase 1 and Phase 2
Responded to therapy- ineligible for Ph2
|
110
|
|
Phase 2
Lost to Follow-up
|
5
|
Baseline Characteristics
Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Anti-tumor Necrosis Factor Agents (Evaluable Population)
n=121 Participants
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis.
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|---|---|
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Age Continuous
|
42.7 years
STANDARD_DEVIATION 11.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).
Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor Agents (Phase 1)
n=121 Participants
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
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|---|---|
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Percentage of Participants With a Clinical Response
Adequate Response
|
90.9 percentage of participants
Interval 85.79 to 96.03
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|
Percentage of Participants With a Clinical Response
Inadequate response
|
9.1 percentage of participants
Interval 3.97 to 14.21
|
SECONDARY outcome
Timeframe: Week 32Population: Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by the investigator and who received second anti-TNF treatment for at least 16 weeks (Phase 2).
High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) \>15 mg/Liter (mg/L);time from onset of disease \<10 years;total spinal pain \>30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) \<4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor Agents (Phase 1)
n=6 Participants
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
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|---|---|
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Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment
|
66.7 percentage of participants
Interval 28.95 to 104.39
|
SECONDARY outcome
Timeframe: Week 32Population: Data was not analyzed as no participant met the criteria for low probability of response in phase 2 of the study.
Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP \> 15 mg/L; time from onset of disease less than \< 10 years; total spinal pain \> 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI \> 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI \< 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 16Population: Analysis population included all participants enrolled in study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting first anti-TNF treatment (Phase 1). N (number of participants analyzed) signifies those participants who had low probability of response and were evaluable for the measure.
Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP \> 15 mg/L; time from onset of disease less than \< 10 years; total spinal pain \> 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI \> 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI \< 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor Agents (Phase 1)
n=28 Participants
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
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|---|---|
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Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16
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96.4 percentage of participants
Interval 89.55 to 103.3
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SECONDARY outcome
Timeframe: Week 16Population: Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).
ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (\>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for \>= 3 domains, and no worsening in remaining domain.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor Agents (Phase 1)
n=121 Participants
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
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|---|---|
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Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
|
33.1 percentage of participants
Interval 24.68 to 41.44
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SECONDARY outcome
Timeframe: Week 16Population: Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor Agents (Phase 1)
n=11 Participants
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
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|---|---|
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Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy
|
72.7 percentage of participants
Interval 46.41 to 99.05
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SECONDARY outcome
Timeframe: Week 32Population: Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by ASAS 40 and who received second anti-TNF treatment for at least 16 weeks (Phase 2).
ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (\>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for \>= 3 domains, and no worsening in remaining domain.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor Agents (Phase 1)
n=6 Participants
Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
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|---|---|
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Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks
|
0 percentage of participants
|
Adverse Events
Anti-tumor Necrosis Factor Agents
Serious adverse events
| Measure |
Anti-tumor Necrosis Factor Agents
n=132 participants at risk
Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study.
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|---|---|
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General disorders
Tonsillar neoplasm
|
0.76%
1/132
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Anti-tumor Necrosis Factor Agents
n=132 participants at risk
Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator's discretion in Phase 2 of the study.
|
|---|---|
|
General disorders
Upper respiratory tract infection
|
2.3%
3/132
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
3.0%
4/132
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gastroenteritis viral
|
0.76%
1/132
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Diarrhoea and vomiting
|
0.76%
1/132
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER