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

NCT01079182 | Completed Results

• 1 other identifier: P10-147
• Study Type: observational
• Target: 4,681
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankylosing Spondylitis

Keywords

Daily practice; Humira; Efficacy; Safety; Ankylosing spondylitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (21)

• Mean Number of Involved Peripheral Joints

  At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months

• Percentage of Participants With Extraspinal Manifestations

  At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months

• Mean Erythrocyte Sedimentation Rate (ESR)

  At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months

• Mean Plasma Concentrations of C-Reactive Protein (CRP)

  At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months

• Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score

  At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months

Study Arms (1)

Ankylosing spondylitis

Participants with ankylosing spondylitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with AS in routine clinical practice.

You may qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Bianca Wittig, MD

  AbbVie Deutschland GmbH & Co. KG, Medical Department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: January 1, 2006
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 9, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-06