bIosimilar of aDalimumab, an European evAluation

NCT05190484 | Unknown

• 1 other identifier: ADAL-004-CNI
• Study Type: observational
• Target: 1,050
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.

Conditions

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

Keywords

adalimumab; biosimilar

Outcome Measures

Primary Outcomes (1)

• TREATMENT DISCONTINUATION

  A patient will be considered to have discontinued FK adalimumab (not persistent) if the investigator reports a permanent discontinuation or if the patient has been more than 90 consecutive days not covered by treatment (based on the refills reported).

  12 months

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

The study population will include male and female adult patients with an IMID who were prescribed FK adalimumab, meet all the study inclusion criteria and none of the exclusion criteria and provide written informed consent to participate.

You may qualify if:

• Age ≥18 years, male or female.
• Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
• Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
• Patients able to understand and complete the study questionnaires in local language during the study visits.
• Patients willing to sign informed consent to meet data protection requirements

You may not qualify if:

• Unwillingness to provide written informed consent.
• Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
• Patients not expected to be available for study visits during 12 months.

Sponsors & Collaborators

• Fresenius Kabi: lead

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; 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

Study Design

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

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 13, 2022
• Study Start: April 30, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: January 13, 2022

Record last verified: 2022-01