Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis

NCT01078571 | Completed Results

• 1 other identifier: P10-077
• Study Type: observational
• Target: 705
• Locations: 1 country
• Sites: 40

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).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Biologic; Tumor Necrosis Factors blockers agents Monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline, 1, 4, 6, and 12 months

Secondary Outcomes (6)

• 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).

  Baseline and 12 months

• 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).

  Baseline and 12 months

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

  Baseline, 1, 4, 6, and 12 months

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

  Baseline and 12 months

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

  Baseline and 12 Months

Study Arms (1)

RA patients in treatment with adalimumab (Humira)

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

Biological: adalimumab (HUMIRA®)

Interventions

adalimumab (HUMIRA®) 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.

Also known as: HUMIRA®, adalimumab

RA patients in treatment with adalimumab (Humira)

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

Rheumatologist consultant

You may qualify if:

• 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

You may not qualify if:

• 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®).

Sponsors & Collaborators

• Abbott: lead

Study Sites (40)

Site Reference ID/Investigator# 29714

A Coruña, 15006, Spain

Location

Site Reference ID/Investigator# 29061

Algeciras, 11207, Spain

Location

Site Reference ID/Investigator# 29710

Almería, 04009, Spain

Location

Site Reference ID/Investigator# 29719

Barcelona, 08003, Spain

Location

Site Reference ID/Investigator# 29054

Barcelona, 08025, Spain

Location

Site Reference ID/Investigator# 29698

Barcelona, 08025, Spain

Location

Site Reference ID/Investigator# 29063

Barcelona, 08035, Spain

Location

Site Reference ID/Investigator# 29718

Barcelona, 08035, Spain

Location

Site Reference ID/Investigator# 29720

Barcelona, 08036, Spain

Location

Site Reference ID/Investigator# 29706

Cadiz, 11009, Spain

Location

Site Reference ID/Investigator# 29052

Calella, 08370, Spain

Location

Site Reference ID/Investigator# 29065

Cartagena, 30203, Spain

Location

Site Reference ID/Investigator# 29713

Córdoba, 14004, Spain

Location

Site Reference ID/Investigator# 29703

El Palmar, 31120, Spain

Location

Site Reference ID/Investigator# 28607

Ferrol, 15405, Spain

Location

Site Reference ID/Investigator# 5338

Girona, 17002, Spain

Location

Site Reference ID/Investigator# 29701

Granada, 18014, Spain

Location

Site Reference ID/Investigator# 29705

Huelva, 21080, Spain

Location

Site Reference ID/Investigator# 29050

Ibiza Town, 07800, Spain

Location

Site Reference ID/Investigator# 29708

Jaén, 23007, Spain

Location

Site Reference ID/Investigator# 29709

Jerez de la Frontera, 11407, Spain

Location

Site Reference ID/Investigator# 29711

L'Hospitalet de Llobregat, 08907, Spain

Location

Site Reference ID/Investigator# 29716

Lugo, 27004, Spain

Location

Site Reference ID/Investigator# 29038

Manacor, 07500, Spain

Location

Site Reference ID/Investigator# 29712

Mataro, Barcelona, 08304, Spain

Location

Site Reference ID/Investigator# 29700

Málaga, 29009, Spain

Location

Site Reference ID/Investigator# 29051

Ourense, 32005, Spain

Location

Site Reference ID/Investigator# 29699

Palma de Mallorca, 07014, Spain

Location

Site Reference ID/Investigator# 29717

Pamplona, 31000, Spain

Location

Site Reference ID/Investigator# 29704

Reus, 43201, Spain

Location

Site Reference ID/Investigator# 29715

Santiago de Compostela, 15706, Spain

Location

Site Reference ID/Investigator# 30823

Seville, 41009, Spain

Location

Site Reference ID/Investigator# 29068

Seville, 41013, Spain

Location

Site Reference ID/Investigator# 29064

Tarragona, 43003, Spain

Location

Site Reference ID/Investigator# 29058

Valls, 43800, Spain

Location

Site Reference ID/Investigator# 29055

Vic, 08500, Spain

Location

Site Reference ID/Investigator# 29697

Vigo, 36204, Spain

Location

Site Reference ID/Investigator# 29059

Vigo, 36211, Spain

Location

Site Reference ID/Investigator# 29702

Vigo/Pontevedra, 36200, Spain

Location

Site Reference ID/Investigator# 29053

Viladecans, 08840, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Ana M Ruiz-Zorrilla, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: May 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 28, 2011
• Results First Posted: October 25, 2011

Record last verified: 2011-10

Locations

ES (40)