Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

NCT01768858 | Completed Results

• 1 other identifier: P13-562
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC) patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or combination therapy with methotrexate (in participants with RA) and to investigate whether there were correlations between such beliefs and adherence to maintenance treatment.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Crohn´s Disease; Ulcerative Colitis; Plaque Psoriasis

Keywords

Arthritis; Morbus Crohn; Adherence; Spondylitis; Ulcerative colitis; Monoclonals; Rheumatoid; Antibodies; Ankylosing; Plaque psoriasis; Psoriatic; Crohn´s disease; Antirheumatic Agents

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months

  The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs.

  Baseline and 12 months

• Correlation Between Beliefs About Medicines Questionnaire (BMQ) Specific Score and Adherence to Treatment as Measured by the Morisky Medication Adherence Scale (MMAS) at 12 Months

  The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs. The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).

  Baseline and 12 months

Secondary Outcomes (7)

• Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12

  At Month 3 and Month 12

• Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12

  At Month 3 and Month 12

• Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time

  Baseline, Month 3, Month 6, Month 9, Month 12

• Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time

  Baseline, Month 3, Month 6, Month 9, Month 12

• Change in C-reactive Protein (CRP) Concentration Over Time

  Baseline, Month 3, Month 6, Month 9, Month 12

Study Arms (1)

Participants receiving adalimumab

Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.

Drug: Adalimumab

Interventions

Adalimumab DRUG

Adalimumab administered by subcutaneous injection, via pre-filled syringe or autoinjector pen

Also known as: Humira, ABT-D2E7

Participants receiving adalimumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants currently being managed in a specialist rheumatology practice or respective hospital department

You may qualify if:

• Participants ≥18 years of age with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC)
• Participants must fulfill international and national guidelines for the use of a biologic disease-modifying antirheumatic drug (bDMARD) in RA, PsA, AS, PS, CD, or UC (chest X-ray and interferon gamma release assay (IGRA) or purified protein derivative (PPD) skin test negative for tuberculosis)
• In addition one of the following criteria must be fulfilled:
• unsatisfactory DMARD response defined as treatment failure with at least two DMARDs including methotrexate in participants with RA or PsA
• unsatisfactory nonsteroidal anti-inflammatory drug (NSAID) response in participants with AS
• unsatisfactory response to prior bDMARDs in participants with RA, PsA, or AS
• unsatisfactory response to, contraindication to, or intolerance to other systemic therapy including cyclosporine, methotrexate, or psoralen with ultraviolet A light (PUVA) in participants with PS
• unsatisfactory response despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or intolerance or medical contraindications for such therapies in CD
• unsatisfactory response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or intolerance to or medical contraindications for such therapies in UC

You may not qualify if:

• Participants who are not covered in the latest version of the adalimumab Summary of Product Characteristics (SPC) for the syringe and pen
• Participants currently enrolled in another study program or clinical trial
• Participants who have been treated with adalimumab before

Sponsors & Collaborators

• AbbVie: lead
• Raffeiner GmbH: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative; Arthritis; Spondylitis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Bone Diseases, Infectious; Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Alexander P Dorr, PhD

  AbbVie Austria

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: February 5, 2013
• Primary Completion: August 13, 2017
• Study Completion: August 13, 2017
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2019-01