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

Rheumatoid Arthritis Clinical Trial

Official title:

A 3-year Post-marketing Observational Study Following up Patients With Moderate to Severe RA Treated With Humira in Greece

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086033
• Other study ID #: PMOS GREC 2004 06
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: September 24, 2013
• Start date: May 2006
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Greece	Site Reference ID/Investigator# 30116	A. Glyfada
Greece	Site Reference ID/Investigator# 47544	Ag. Dimitrios, Athens
Greece	Site Reference ID/Investigator# 47542	Ag. Paraskevi, Athens
Greece	Site Reference ID/Investigator# 29954	Agioi Anargyroi
Greece	Site Reference ID/Investigator# 29992	Agioi Anargyroi
Greece	Site Reference ID/Investigator# 29915	Alexandroupoli
Greece	Site Reference ID/Investigator# 30118	Arta
Greece	Site Reference ID/Investigator# 29899	Athens
Greece	Site Reference ID/Investigator# 29914	Athens
Greece	Site Reference ID/Investigator# 29944	Athens
Greece	Site Reference ID/Investigator# 29950	Athens
Greece	Site Reference ID/Investigator# 29953	Athens
Greece	Site Reference ID/Investigator# 29989	Athens
Greece	Site Reference ID/Investigator# 30085	Athens
Greece	Site Reference ID/Investigator# 30178	Athens
Greece	Site Reference ID/Investigator# 30472	Athens
Greece	Site Reference ID/Investigator# 30474	Athens
Greece	Site Reference ID/Investigator# 30479	Athens
Greece	Site Reference ID/Investigator# 30480	Athens
Greece	Site Reference ID/Investigator# 30785	Athens
Greece	Site Reference ID/Investigator# 30788	Athens
Greece	Site Reference ID/Investigator# 5284	Athens
Greece	Site Reference ID/Investigator# 30198	Chalkida
Greece	Site Reference ID/Investigator# 29828	Crete
Greece	Site Reference ID/Investigator# 30008	Crete
Greece	Site Reference ID/Investigator# 30210	Crete
Greece	Site Reference ID/Investigator# 30105	Drama
Greece	Site Reference ID/Investigator# 29820	Elefsina
Greece	Site Reference ID/Investigator# 30146	Ermoupolis Syros
Greece	Site Reference ID/Investigator# 30767	Heraklion Crete
Greece	Site Reference ID/Investigator# 30789	Holargos
Greece	Site Reference ID/Investigator# 30482	Ioannina
Greece	Site Reference ID/Investigator# 47322	Karditsa
Greece	Site Reference ID/Investigator# 29850	Katerini
Greece	Site Reference ID/Investigator# 30189	Kavala
Greece	Site Reference ID/Investigator# 30476	Kifisia
Greece	Site Reference ID/Investigator# 30004	Kozani
Greece	Site Reference ID/Investigator# 29993	Lamia
Greece	Site Reference ID/Investigator# 29988	Larisa
Greece	Site Reference ID/Investigator# 30770	Larissa
Greece	Site Reference ID/Investigator# 29922	Nikea
Greece	Site Reference ID/Investigator# 29916	Patras
Greece	Site Reference ID/Investigator# 29972	Patras
Greece	Site Reference ID/Investigator# 29827	Peristeri
Greece	Site Reference ID/Investigator# 29936	Pyrgos
Greece	Site Reference ID/Investigator# 30200	Rion, Patras
Greece	Site Reference ID/Investigator# 29845	Thessaloniki
Greece	Site Reference ID/Investigator# 29900	Thessaloniki
Greece	Site Reference ID/Investigator# 29924	Thessaloniki
Greece	Site Reference ID/Investigator# 29947	Thessaloniki
Greece	Site Reference ID/Investigator# 30165	Thessaloniki
Greece	Site Reference ID/Investigator# 30192	Thessaloniki
Greece	Site Reference ID/Investigator# 30477	Thessaloniki
Greece	Site Reference ID/Investigator# 30765	Thessaloniki
Greece	Site Reference ID/Investigator# 30791	Thessaloniki
Greece	Site Reference ID/Investigator# 30792	Thessaloniki
Greece	Site Reference ID/Investigator# 47543	Thessaloniki
Greece	Site Reference ID/Investigator# 30115	Trikala
Greece	Site Reference ID/Investigator# 30084	Veria
Greece	Site Reference ID/Investigator# 29968	Xanthi

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.; If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.	3 years	Yes
Primary	Disease Activity Score (DAS) 28 Over Time	The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36	No
Primary	European League Against Rheumatism (EULAR) Response	A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.; A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of = 3.2.; A Moderate EULAR Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and = 1.2 from Baseline and attainment of a DAS28 score of = 5.1, or; an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.; No Response is defined as either: an improvement (decrease) in the DAS28 of = to 0.6, or; an improvement (decrease) in the DAS28 of > 0.6 and = 1.2 and attainment of a DAS28 of > 5.1.	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36	No
Primary	Number of Participants With an American College of Rheumatology (ACR) 20 Response	American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: = 20% improvement in tender joint count; = 20% improvement in swollen joint count; and; = 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); Acute phase reactant value (C-reactive protein [CRP]).	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36	No
Primary	Number of Participants With an American College of Rheumatology (ACR) 50 Response	American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: = 50% improvement in tender joint count; = 50% improvement in swollen joint count; and; = 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); Acute phase reactant value (C-reactive protein [CRP]).	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36	No
Primary	Number of Participants With an American College of Rheumatology (ACR) 70 Response	American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: = 70% improvement in tender joint count; = 70% improvement in swollen joint count; and; = 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); Acute phase reactant value (C-reactive protein [CRP]).	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36	No
Secondary	Percentage of Participants Who Missed at Least One Dose of Humira	Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.	Months 3, 6, 9, 12, 18, 24, 30, and 36	No

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