Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis

Condition(s) targeted: Rheumatoid Arthritis

Intervention: adalimumab (HUMIRA®) (Biological)

Phase: N/A

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Ana M Ruiz-Zorrilla, MD, Study Director, Affiliation: Abbott

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).

Official title: Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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

Secondary outcome:

Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).

Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).

Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.

Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.

Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.

Radiological Evaluation of Rheumatoid Arthritis (RA).

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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®).

Site Reference ID/Investigator# 29714, A Coruna 15006, Spain

Site Reference ID/Investigator# 29061, Algeciras 11207, Spain

Site Reference ID/Investigator# 29710, Almeria 04009, Spain

Site Reference ID/Investigator# 29054, Barcelona 08025, Spain

Site Reference ID/Investigator# 29063, Barcelona 08035, Spain

Site Reference ID/Investigator# 29698, Barcelona 08025, Spain

Site Reference ID/Investigator# 29718, Barcelona 08035, Spain

Site Reference ID/Investigator# 29719, Barcelona 08003, Spain

Site Reference ID/Investigator# 29720, Barcelona 08036, Spain

Site Reference ID/Investigator# 29706, Cadiz 11009, Spain

Site Reference ID/Investigator# 29052, Calella 08370, Spain

Site Reference ID/Investigator# 29065, Cartagena 30203, Spain

Site Reference ID/Investigator# 29713, Cordoba 14004, Spain

Site Reference ID/Investigator# 29703, El Palmar 31120, Spain

Site Reference ID/Investigator# 28607, Ferrol 15405, Spain

Site Reference ID/Investigator# 5338, Girona 17002, Spain

Site Reference ID/Investigator# 29701, Granada 18014, Spain

Site Reference ID/Investigator# 29711, Hospitalet de Llobregat 08907, Spain

Site Reference ID/Investigator# 29705, Huelva 21080, Spain

Site Reference ID/Investigator# 29050, Ibiza 07800, Spain

Site Reference ID/Investigator# 29708, Jaen 23007, Spain

Site Reference ID/Investigator# 29709, Jerez 11407, Spain

Site Reference ID/Investigator# 29716, Lugo 27004, Spain

Site Reference ID/Investigator# 29700, Malaga 29009, Spain

Site Reference ID/Investigator# 29038, Manacor 07500, Spain

Site Reference ID/Investigator# 29712, Mataro, Barcelona 08304, Spain

Site Reference ID/Investigator# 29051, Orense 32005, Spain

Site Reference ID/Investigator# 29699, Palma de Mallorca 07014, Spain

Site Reference ID/Investigator# 29717, Pamplona 31000, Spain

Site Reference ID/Investigator# 29704, Reus 43201, Spain

Site Reference ID/Investigator# 29715, Santiago de Compostela 15706, Spain

Site Reference ID/Investigator# 29068, Sevilla 41013, Spain

Site Reference ID/Investigator# 30823, Seville 41009, Spain

Site Reference ID/Investigator# 29064, Tarragona 43003, Spain

Site Reference ID/Investigator# 29058, Valls 43800, Spain

Site Reference ID/Investigator# 29055, Vic 08500, Spain

Site Reference ID/Investigator# 29702, Vigo/Pontevedra 36200, Spain

Site Reference ID/Investigator# 29059, Vigo 36211, Spain

Site Reference ID/Investigator# 29697, Vigo 36204, Spain

Site Reference ID/Investigator# 29053, Viladecans 08840, Spain

Starting date: May 2006
Last updated: October 26, 2011