Clinical trial NCT01079182: Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
Official title: Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Daily practice
Humira
Efficacy
Safety
Ankylosing spondylitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 4681
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with AS in routine clinical practice.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Number of Participants With Drug-Related Adverse Events (AEs)
timeFrame: From signing of informed consent up to 24 months
Secondary outcomes:
measure: Mean Number of Involved Peripheral Joints
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants With Extraspinal Manifestations
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Erythrocyte Sedimentation Rate (ESR)
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Plasma Concentrations of C-Reactive Protein (CRP)
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Global Assessment of Disease Activity Score
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Participant Fatigue Score
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Participant Pain Score
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants With Morning Stiffness
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Duration of Morning Stiffness
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria
timeFrame: At 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants Achieving ASAS Partial Remission Criteria
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants on Adalimumab Monotherapy
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
measure: Mean Equivalent Dose of Prednisolone
timeFrame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Deutschland GmbH & Co. KG, Medical Department
name: Bianca Wittig, MD
role: STUDY_DIRECTOR
References: