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

AbbVie

Status: Completed

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

Treatments: Drug: Adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01768858

P13-562

Details and patient eligibility

About

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.

Full description

Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of a participant to an adalimumab-containing regimen was decided in advance and was to be current practice. The prescribing of adalimumab was clearly separated from the decision to include the participant in the study. Participants were observed for a maximum of 12 months, with a total of 5 study visits (Screening = Visit 1).

Enrollment: 96 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  1. unsatisfactory DMARD response defined as treatment failure with at least two DMARDs including methotrexate in participants with RA or PsA
  2. unsatisfactory nonsteroidal anti-inflammatory drug (NSAID) response in participants with AS
  3. unsatisfactory response to prior bDMARDs in participants with RA, PsA, or AS
  4. 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
  5. 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
  6. 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

Exclusion criteria

• 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

Trial design

96 participants in 1 patient group

Participants receiving adalimumab

Description:

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.

Treatment:

Drug: Adalimumab