Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis (DALI)

Abbott

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: adalimumab (HUMIRA®)

Study type: Observational

Funder types: Industry

Identifiers

NCT01078571

P10-077

Details and patient eligibility

About

Adalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more recent marketing authorization, and as a result of this, there are only efficacy and safety data from clinical trials with controlled conditions.The study will evaluate the safety and effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with several types of patients showing concomitant treatments or diseases and compliance. Among the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less investigated in the common clinical practice because of, as a result of its recent marketing, it was not included in the BIOBADASER (Data Base for Biological Products in Spain, Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of Rheumatology ) in which was determined an association between infliximab therapy and the risk of developing active tuberculosis. To ensure the maintaining of the strict common physician practice (no prescription induction), and following the recommendations of the SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) consensus documents, it will be selected only those patients that were already in treatment with adalimumab (HUMIRA),(except patients involved in clinical studies with Adalimumab), and had shown good response, or those that fulfilled treatment indication in accordance with the SER recommendations and following the Summary of Products Characteristics of adalimumab (HUMIRA).

Full description

Main objective

• To evaluate safety and tolerability of adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions.

Secondary objectives

• To evaluate the effectiveness of the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions in accordance with SER recommendations:
• To evaluate the life quality associated to the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions.
• To describe the profile of patients who are in treatment with adalimumab (HUMIRA) biological therapy.

Enrollment: 705 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years
• Patients who underwent adalimumab treatment at least for the previous 4 months before baseline visit, who have a good therapeutic response to treatment and have not been involved in previous clinical studies with Adalimumab or
• Patients who previously to the baseline visit, have been prescribe adalimumab complying treatment indication according to SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) recommendations:
• Patients who had provided informed consent.
• Patients who have been prescribed adalimumab according to the Summary of Product Characteristics

Exclusion criteria

• Patients in whom a continued 12- months follow up is not anticipated.
• The contraindications specified in the Summary of Products Characteristics
• Hypersensibility to some of the components of the medication to administer.
• Any pathology shown by the patient that, according to medical criterion, contraindicates the treatment indicated in the protocol according to the Summary of Products Characteristics of adalimumab (HUMIRA®).

Trial design

705 participants in 1 patient group

RA patients in treatment with adalimumab (Humira)

Description:

RA patients in treatment with adalimumab (Humira) at 40mg alternate weeks

Treatment:

Biological: adalimumab (HUMIRA®)