A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

NCT05051943 | Completed

• 1 other identifier: ADAL-001-CNI
• Study Type: observational
• Target: 754
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.

Conditions

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

Keywords

nutrition

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression (CGI)

  The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.

  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

Adults patients with rhumatologic, gastrologic or dermatologic disease eligible to a treatment with adalimumab

You may qualify if:

• Patients at least 18 years old who agree to participate in the study and do not object to the use of their health data
• A disorder treated with anti-TNF therapy
• Whose physician made the decision to initiate adalimumab treatment prior to the study

You may not qualify if:

• Patients who are unwilling or unable to fulfil follow-up requirements (patients who cannot be reached by phone or complete the self-administered questionnaire or not fluent in French

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

CHRU de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurent Peyrin-Biroulet, MD

  CHU NANCY

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 21, 2021
• Study Start: September 29, 2020
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

FR (1)