Clinical trial NCT01086033: A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece
Official title: A 3-year Post-marketing Observational Study Following up Patients With Moderate to Severe RA Treated With Humira in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Evaluation of safety and efficacy
Adalimumab treatment
Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 3 years
measure: Disease Activity Score (DAS) 28 Over Time
timeFrame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
measure: European League Against Rheumatism (EULAR) Response
timeFrame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
measure: Number of Participants With an American College of Rheumatology (ACR) 20 Response
timeFrame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
measure: Number of Participants With an American College of Rheumatology (ACR) 50 Response
timeFrame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
measure: Number of Participants With an American College of Rheumatology (ACR) 70 Response
timeFrame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Secondary outcomes:
measure: Percentage of Participants Who Missed at Least One Dose of Humira
timeFrame: Months 3, 6, 9, 12, 18, 24, 30, and 36
Other outcomes:
Locations:
city: A. Glyfada
country: Greece
facility: Site Reference ID/Investigator# 30116
city: Ag. Dimitrios, Athens
country: Greece
facility: Site Reference ID/Investigator# 47544
city: Ag. Paraskevi, Athens
country: Greece
facility: Site Reference ID/Investigator# 47542
city: Agioi Anargyroi
country: Greece
facility: Site Reference ID/Investigator# 29992
city: Agioi Anargyroi
country: Greece
facility: Site Reference ID/Investigator# 29954
city: Alexandroupoli
country: Greece
facility: Site Reference ID/Investigator# 29915
city: Arta
country: Greece
facility: Site Reference ID/Investigator# 30118
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29989
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29914
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29950
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 5284
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29944
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30474
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29953
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30085
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30472
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30479
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30480
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29899
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30178
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30785
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30788
city: Chalkida
country: Greece
facility: Site Reference ID/Investigator# 30198
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 30008
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 30210
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 29828
city: Drama
country: Greece
facility: Site Reference ID/Investigator# 30105
city: Elefsina
country: Greece
facility: Site Reference ID/Investigator# 29820
city: Ermoupolis Syros
country: Greece
facility: Site Reference ID/Investigator# 30146
city: Heraklion Crete
country: Greece
facility: Site Reference ID/Investigator# 30767
city: Holargos
country: Greece
facility: Site Reference ID/Investigator# 30789
city: Ioannina
country: Greece
facility: Site Reference ID/Investigator# 30482
city: Karditsa
country: Greece
facility: Site Reference ID/Investigator# 47322
city: Katerini
country: Greece
facility: Site Reference ID/Investigator# 29850
city: Kavala
country: Greece
facility: Site Reference ID/Investigator# 30189
city: Kifisia
country: Greece
facility: Site Reference ID/Investigator# 30476
city: Kozani
country: Greece
facility: Site Reference ID/Investigator# 30004
city: Lamia
country: Greece
facility: Site Reference ID/Investigator# 29993
city: Larisa
country: Greece
facility: Site Reference ID/Investigator# 29988
city: Larissa
country: Greece
facility: Site Reference ID/Investigator# 30770
city: Nikea
country: Greece
facility: Site Reference ID/Investigator# 29922
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 29972
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 29916
city: Peristeri
country: Greece
facility: Site Reference ID/Investigator# 29827
city: Pyrgos
country: Greece
facility: Site Reference ID/Investigator# 29936
city: Rion, Patras
country: Greece
facility: Site Reference ID/Investigator# 30200
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 29900
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30192
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30165
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30765
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 29845
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30791
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30792
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 47543
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 29924
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30477
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 29947
city: Trikala
country: Greece
facility: Site Reference ID/Investigator# 30115
city: Veria
country: Greece
facility: Site Reference ID/Investigator# 30084
city: Xanthi
country: Greece
facility: Site Reference ID/Investigator# 29968
Study officials:
affiliation: AbbVie Pharmaceuticals S.A.
name: Thanasis Floros, MD
role: STUDY_CHAIR
References: