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

Ankylosing Spondylitis Clinical Trial

Official title:

Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079182
• Other study ID #: P10-147
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: June 10, 2015
• Start date: January 2006
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4681
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Primary	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).	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Primary	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.	From signing of informed consent up to 24 months	Yes
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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).	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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).	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months		At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months		At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months		At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months		At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	Percentage of Participants on Adalimumab Monotherapy		At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)		At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	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.	At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months	No
Secondary	Mean Equivalent Dose of Prednisolone	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	No

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