Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)

June 10, 2015 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4681

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with AS in routine clinical practice.

Description

Inclusion Criteria:

  1. Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
  2. Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
  3. No contraindications for anti-tumor necrosis factors (TNF) therapy.

Exclusion Criteria:

1. Participants who do not meet the above listed inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Ankylosing spondylitis
Participants with ankylosing spondylitis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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).
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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.
From signing of informed consent up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Number of Involved Peripheral Joints
Time Frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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.
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
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.
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
Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
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
Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
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
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.
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
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.
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
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).
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
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).
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
Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.
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
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.
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
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.
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
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.
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
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.
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
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
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
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
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
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
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
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.
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
The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.
At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P10-147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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