Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis

NCT ID: NCT01078571

Last Updated: 2011-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 705 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-05-31

Brief Summary

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).

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RA patients in treatment with adalimumab (Humira)

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

adalimumab (HUMIRA®)

Intervention Type: BIOLOGICAL

The primary objective of the study is to evaluate the safety and tolerability of adalimumab (HUMIRA®) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis (RA) patients under usual practice conditions.

Interventions

adalimumab (HUMIRA®)

The primary objective of the study is to evaluate the safety and tolerability of adalimumab (HUMIRA®) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis (RA) patients under usual practice conditions.

Intervention Type: BIOLOGICAL

Other Intervention Names

HUMIRA®; adalimumab

Eligibility 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®).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana M Ruiz-Zorrilla, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 29714

A Coruña, , Spain

Site Reference ID/Investigator# 29061

Algeciras, , Spain

Site Reference ID/Investigator# 29710

Almería, , Spain

Site Reference ID/Investigator# 29719

Barcelona, , Spain

Site Reference ID/Investigator# 29054

Barcelona, , Spain

Site Reference ID/Investigator# 29698

Barcelona, , Spain

Site Reference ID/Investigator# 29063

Barcelona, , Spain

Site Reference ID/Investigator# 29718

Barcelona, , Spain

Site Reference ID/Investigator# 29720

Barcelona, , Spain

Site Reference ID/Investigator# 29706

Cadiz, , Spain

Site Reference ID/Investigator# 29052

Calella, , Spain

Site Reference ID/Investigator# 29065

Cartagena, , Spain

Site Reference ID/Investigator# 29713

Córdoba, , Spain

Site Reference ID/Investigator# 29703

El Palmar, , Spain

Site Reference ID/Investigator# 28607

Ferrol, , Spain

Site Reference ID/Investigator# 5338

Girona, , Spain

Site Reference ID/Investigator# 29701

Granada, , Spain

Site Reference ID/Investigator# 29705

Huelva, , Spain

Site Reference ID/Investigator# 29050

Ibiza Town, , Spain

Site Reference ID/Investigator# 29708

Jaén, , Spain

Site Reference ID/Investigator# 29709

Jerez de la Frontera, , Spain

Site Reference ID/Investigator# 29711

L'Hospitalet de Llobregat, , Spain

Site Reference ID/Investigator# 29716

Lugo, , Spain

Site Reference ID/Investigator# 29038

Manacor, , Spain

Site Reference ID/Investigator# 29712

Mataro, Barcelona, , Spain

Site Reference ID/Investigator# 29700

Málaga, , Spain

Site Reference ID/Investigator# 29051

Ourense, , Spain

Site Reference ID/Investigator# 29699

Palma de Mallorca, , Spain

Site Reference ID/Investigator# 29717

Pamplona, , Spain

Site Reference ID/Investigator# 29704

Reus, , Spain

Site Reference ID/Investigator# 29715

Santiago de Compostela, , Spain

Site Reference ID/Investigator# 30823

Seville, , Spain

Site Reference ID/Investigator# 29068

Seville, , Spain

Site Reference ID/Investigator# 29064

Tarragona, , Spain

Site Reference ID/Investigator# 29058

Valls, , Spain

Site Reference ID/Investigator# 29055

Vic, , Spain

Site Reference ID/Investigator# 29697

Vigo, , Spain

Site Reference ID/Investigator# 29059

Vigo, , Spain

Site Reference ID/Investigator# 29702

Vigo/Pontevedra, , Spain

Site Reference ID/Investigator# 29053

Viladecans, , Spain

Countries

Spain

Other Identifiers

P10-077

Identifier Type: -

Identifier Source: org_study_id