Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)
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.
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®).
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment
Outcome Description:
The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.
Outcome Time Frame:
Baseline, 1, 4, 6, and 12 months
Safety Issue:
Yes
Principal Investigator
Ana M Ruiz-Zorrilla, MD
Investigator Role:
Study Director
Investigator Affiliation:
Abbott
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
P10-077
NCT ID:
NCT01078571
Start Date:
May 2006
Completion Date:
May 2010
Related Keywords:
- Rheumatoid Arthritis
- Rheumatoid Arthritis
- Biologic
- Tumor Necrosis Factors blockers agents Monoclonal antibody
- Arthritis
- Arthritis, Rheumatoid
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