MedDataX Logo

A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece

NCT ID: NCT01086033

Last Updated: 2013-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

566 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objectives of the study are to observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization and to observe compliance of patients with the prescribed treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.

Once the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up with the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data, if they are part of clinical routine, will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Evaluation of safety and efficacy Adalimumab treatment Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Humira

Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving Humira (adalimumab) under normal clinical practice for at least one month prior to inclusion and according to the approved Summary of Product Characteristics (SPC) in the European Union.
* Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria

* Contraindications according to the SPC.
* Patients should not participate in another observational Abbott study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thanasis Floros, MD

Role: STUDY_CHAIR

AbbVie Pharmaceuticals S.A.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 30116

A. Glyfada, , Greece

Site Status

Site Reference ID/Investigator# 47544

Ag. Dimitrios, Athens, , Greece

Site Status

Site Reference ID/Investigator# 47542

Ag. Paraskevi, Athens, , Greece

Site Status

Site Reference ID/Investigator# 29915

Alexandroupoli, , Greece

Site Status

Site Reference ID/Investigator# 30118

Arta, , Greece

Site Status

Site Reference ID/Investigator# 29989

Athens, , Greece

Site Status

Site Reference ID/Investigator# 29914

Athens, , Greece

Site Status

Site Reference ID/Investigator# 29950

Athens, , Greece

Site Status

Site Reference ID/Investigator# 5284

Athens, , Greece

Site Status

Site Reference ID/Investigator# 29944

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30474

Athens, , Greece

Site Status

Site Reference ID/Investigator# 29953

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30085

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30472

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30479

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30480

Athens, , Greece

Site Status

Site Reference ID/Investigator# 29899

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30178

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30785

Athens, , Greece

Site Status

Site Reference ID/Investigator# 30788

Athens, , Greece

Site Status

Site Reference ID/Investigator# 29992

Ágioi Anárgyroi, , Greece

Site Status

Site Reference ID/Investigator# 29954

Ágioi Anárgyroi, , Greece

Site Status

Site Reference ID/Investigator# 30198

Chalcis, , Greece

Site Status

Site Reference ID/Investigator# 30789

Cholargós, , Greece

Site Status

Site Reference ID/Investigator# 30008

Crete, , Greece

Site Status

Site Reference ID/Investigator# 30210

Crete, , Greece

Site Status

Site Reference ID/Investigator# 29828

Crete, , Greece

Site Status

Site Reference ID/Investigator# 30105

Drama, , Greece

Site Status

Site Reference ID/Investigator# 29820

Elefsina, , Greece

Site Status

Site Reference ID/Investigator# 30146

Ermoupolis Syros, , Greece

Site Status

Site Reference ID/Investigator# 30767

Heraklion Crete, , Greece

Site Status

Site Reference ID/Investigator# 30482

Ioannina, , Greece

Site Status

Site Reference ID/Investigator# 47322

Karditsa, , Greece

Site Status

Site Reference ID/Investigator# 29850

Katerini, , Greece

Site Status

Site Reference ID/Investigator# 30189

Kavala, , Greece

Site Status

Site Reference ID/Investigator# 30476

Kifissia, , Greece

Site Status

Site Reference ID/Investigator# 30004

Kozani, , Greece

Site Status

Site Reference ID/Investigator# 29993

Lamia, , Greece

Site Status

Site Reference ID/Investigator# 30770

Larissa, , Greece

Site Status

Site Reference ID/Investigator# 29988

Larissa, , Greece

Site Status

Site Reference ID/Investigator# 29922

Nikaia, , Greece

Site Status

Site Reference ID/Investigator# 29972

Pátrai, , Greece

Site Status

Site Reference ID/Investigator# 29916

Pátrai, , Greece

Site Status

Site Reference ID/Investigator# 29827

Peristeri, , Greece

Site Status

Site Reference ID/Investigator# 29936

Pýrgos, , Greece

Site Status

Site Reference ID/Investigator# 30200

Rion, Patras, , Greece

Site Status

Site Reference ID/Investigator# 29900

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 30192

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 30165

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 30765

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 29845

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 30791

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 30792

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 47543

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 29924

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 30477

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 29947

Thessaloniki, , Greece

Site Status

Site Reference ID/Investigator# 30115

Trikala, , Greece

Site Status

Site Reference ID/Investigator# 30084

Véria, , Greece

Site Status

Site Reference ID/Investigator# 29968

Xánthi, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Related Links

Access external resources that provide additional context or updates about the study.

http://rxabbvie.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PMOS GREC 2004 06

Identifier Type: -

Identifier Source: org_study_id