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

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT01086033

Acronym / sponsor ID

PMOS GREC 2004 06

Conditions

Rheumatoid Arthritis

Keywords

Evaluation of safety and efficacy, Adalimumab treatment, Rheumatoid Arthritis

Study type

Observational

Recruitment status

Completed

Enrolment

566 participants (actual)

Lead sponsor

AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)

Study start

May 2006

Primary completion

Jul 2012 (actual)

Study completion

Jul 2012 (actual)

First posted

12 Mar 2010 (estimated)

Results

Posted 26 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Number of Participants With Adverse Events

   Time frame: 3 years

   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.

2. Disease Activity Score (DAS) 28 Over Time

   Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

   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.

3. European League Against Rheumatism (EULAR) Response

   Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

   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.

4. Number of Participants With an American College of Rheumatology (ACR) 20 Response

   Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

   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]).

5. Number of Participants With an American College of Rheumatology (ACR) 50 Response

   Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

   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]).

6. Number of Participants With an American College of Rheumatology (ACR) 70 Response

   Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

   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]).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

60 sites in 1 country: see every site and its status.