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

NCT01086033 | Completed Results

• 1 other identifier: PMOS GREC 2004 06
• Study Type: observational
• Target: 566
• Locations: 1 country
• Sites: 60

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.

Conditions

Rheumatoid Arthritis

Keywords

Evaluation of safety and efficacy; Adalimumab treatment; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Percentage of Participants Who Missed at Least One Dose of Humira

  Months 3, 6, 9, 12, 18, 24, 30, and 36

Study Arms (1)

Humira

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

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

Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment

You may qualify if:

• Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

You may not qualify if:

• Contraindications according to the SPC.
• Patients should not participate in another observational Abbott study.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (60)

Site Reference ID/Investigator# 30116

A. Glyfada, Greece

Location

Site Reference ID/Investigator# 47544

Ag. Dimitrios, Athens, 17121, Greece

Location

Site Reference ID/Investigator# 47542

Ag. Paraskevi, Athens, 15343, Greece

Location

Site Reference ID/Investigator# 29915

Alexandroupoli, 68100, Greece

Location

Site Reference ID/Investigator# 30118

Arta, 47100, Greece

Location

Site Reference ID/Investigator# 29989

Athens, 10444, Greece

Location

Site Reference ID/Investigator# 29914

Athens, 115 21, Greece

Location

Site Reference ID/Investigator# 29950

Athens, 115 25, Greece

Location

Site Reference ID/Investigator# 5284

Athens, 115 25, Greece

Location

Site Reference ID/Investigator# 29944

Athens, 115 27, Greece

Location

Site Reference ID/Investigator# 30474

Athens, 115 27, Greece

Location

Site Reference ID/Investigator# 29953

Athens, 11521, Greece

Location

Site Reference ID/Investigator# 30085

Athens, 11521, Greece

Location

Site Reference ID/Investigator# 30472

Athens, 11521, Greece

Location

Site Reference ID/Investigator# 30479

Athens, 11527, Greece

Location

Site Reference ID/Investigator# 30480

Athens, 11527, Greece

Location

Site Reference ID/Investigator# 29899

Athens, 11528, Greece

Location

Site Reference ID/Investigator# 30178

Athens, 11635, Greece

Location

Site Reference ID/Investigator# 30785

Athens, 12462, Greece

Location

Site Reference ID/Investigator# 30788

Athens, 12462, Greece

Location

Site Reference ID/Investigator# 29992

Ágioi Anárgyroi, 13122, Greece

Location

Site Reference ID/Investigator# 29954

Ágioi Anárgyroi, Greece

Location

Site Reference ID/Investigator# 30198

Chalcis, 34100, Greece

Location

Site Reference ID/Investigator# 30789

Cholargós, 15562, Greece

Location

Site Reference ID/Investigator# 30008

Crete, 71201, Greece

Location

Site Reference ID/Investigator# 30210

Crete, 74100, Greece

Location

Site Reference ID/Investigator# 29828

Crete, Greece

Location

Site Reference ID/Investigator# 30105

Drama, 66100, Greece

Location

Site Reference ID/Investigator# 29820

Elefsina, 19200, Greece

Location

Site Reference ID/Investigator# 30146

Ermoupolis Syros, Greece

Location

Site Reference ID/Investigator# 30767

Heraklion Crete, 70013, Greece

Location

Site Reference ID/Investigator# 30482

Ioannina, 45500, Greece

Location

Site Reference ID/Investigator# 47322

Karditsa, 43100, Greece

Location

Site Reference ID/Investigator# 29850

Katerini, Greece

Location

Site Reference ID/Investigator# 30189

Kavala, 65302, Greece

Location

Site Reference ID/Investigator# 30476

Kifissia, 14500, Greece

Location

Site Reference ID/Investigator# 30004

Kozani, 50100, Greece

Location

Site Reference ID/Investigator# 29993

Lamia, 35100, Greece

Location

Site Reference ID/Investigator# 30770

Larissa, 411 10, Greece

Location

Site Reference ID/Investigator# 29988

Larissa, 41223, Greece

Location

Site Reference ID/Investigator# 29922

Nikaia, 18454, Greece

Location

Site Reference ID/Investigator# 29972

Pátrai, 26221, Greece

Location

Site Reference ID/Investigator# 29916

Pátrai, 26335, Greece

Location

Site Reference ID/Investigator# 29827

Peristeri, 12134, Greece

Location

Site Reference ID/Investigator# 29936

Pýrgos, Greece

Location

Site Reference ID/Investigator# 30200

Rion, Patras, 265 00, Greece

Location

Site Reference ID/Investigator# 29900

Thessaloniki, 54622, Greece

Location

Site Reference ID/Investigator# 30192

Thessaloniki, 54622, Greece

Location

Site Reference ID/Investigator# 30165

Thessaloniki, 54623, Greece

Location

Site Reference ID/Investigator# 30765

Thessaloniki, 54636, Greece

Location

Site Reference ID/Investigator# 29845

Thessaloniki, 54639, Greece

Location

Site Reference ID/Investigator# 30791

Thessaloniki, 54642, Greece

Location

Site Reference ID/Investigator# 30792

Thessaloniki, 54642, Greece

Location

Site Reference ID/Investigator# 47543

Thessaloniki, 54643, Greece

Location

Site Reference ID/Investigator# 29924

Thessaloniki, 55134, Greece

Location

Site Reference ID/Investigator# 30477

Thessaloniki, 564 29, Greece

Location

Site Reference ID/Investigator# 29947

Thessaloniki, 570 10, Greece

Location

Site Reference ID/Investigator# 30115

Trikala, 42100, Greece

Location

Site Reference ID/Investigator# 30084

Véria, Greece

Location

Site Reference ID/Investigator# 29968

Xánthi, 67100, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Thanasis Floros, MD

  AbbVie Pharmaceuticals S.A.

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 12, 2010
• Study Start: May 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 26, 2013
• Results First Posted: September 26, 2013

Record last verified: 2013-09

Locations

GR (60)