Ankylosing SpondylitisNCT01079182
Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
An observational study of Ankylosing Spondylitis, run by AbbVie (prior sponsor, Abbott).
Trial summary
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 4,681 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with AS in routine clinical practice.
Who may be able to join
- Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
- Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
- No contraindications for anti-tumor necrosis factors (TNF) therapy.
Who cannot join
- 1. Participants who do not meet the above listed inclusion criteria.
About this study
Official title: Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
Read the detailed description
This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Daily practice, Humira, Efficacy, Safety, Ankylosing spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing spondylitis | Participants with ankylosing spondylitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Number of Participants With Drug-Related Adverse Events (AEs)
An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.
Measured: From signing of informed consent up to 24 months
Secondary outcomes (21)
Mean Number of Involved Peripheral Joints
Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Extraspinal Manifestations
Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Erythrocyte Sedimentation Rate (ESR)
Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score
The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Global Assessment of Disease Activity Score
Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Participant Fatigue Score
Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Participant Pain Score
Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Morning Stiffness
Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Duration of Morning Stiffness
Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria
This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.
Measured: At 3, 6, 9, 12, 18, and 24 months
Percentage of Participants Achieving ASAS Partial Remission Criteria
This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks
The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants on Adalimumab Monotherapy
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents
Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Equivalent Dose of Prednisolone
The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.
Measured: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startJan 2006
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,681 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bianca Wittig, MD, Study director, AbbVie Deutschland GmbH & Co. KG, Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079182
- Sponsor's protocol ID
- P10-147
- Status last verified
- Jun 2015
- First submitted
- 1 Mar 2010
- Last updated
- 9 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01079182
- Acronym / sponsor ID
- P10-147
- Conditions
- Ankylosing Spondylitis
- Keywords
- Daily practice, Humira, Efficacy, Safety, Ankylosing spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,681 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
Detailed description
This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankylosing spondylitis | – | –Participants with ankylosing spondylitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with AS in routine clinical practice.
Key inclusion criteria (3 listed)
- Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
- Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
- No contraindications for anti-tumor necrosis factors (TNF) therapy.
Key exclusion criteria (1 listed)
- 1. Participants who do not meet the above listed inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).
Number of Participants With Drug-Related Adverse Events (AEs)
Time frame: From signing of informed consent up to 24 months
An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.
21 secondary outcomes
Mean Number of Involved Peripheral Joints
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Extraspinal Manifestations
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Erythrocyte Sedimentation Rate (ESR)
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Global Assessment of Disease Activity Score
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Participant Fatigue Score
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Participant Pain Score
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Morning Stiffness
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Duration of Morning Stiffness
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria
Time frame: At 3, 6, 9, 12, 18, and 24 months
Percentage of Participants Achieving ASAS Partial Remission Criteria
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants on Adalimumab Monotherapy
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Mean Equivalent Dose of Prednisolone
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bianca Wittig, MD study director
AbbVie Deutschland GmbH & Co. KG, Medical Department
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.