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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01086033
First received: February 26, 2010
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A 3-year Post-marketing Observational Study Following up Patients With Moderate to Severe RA Treated With Humira in Greece

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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.


  • Disease Activity Score (DAS) 28 Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]
    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.

  • European League Against Rheumatism (EULAR) Response [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]

    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.

  • 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 ] [ Designated as safety issue: No ]

    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]).

  • 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 ] [ Designated as safety issue: No ]

    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]).

  • 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 ] [ Designated as safety issue: No ]

    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]).


Secondary Outcome Measures:
  • Percentage of Participants Who Missed at Least One Dose of Humira [ Time Frame: Months 3, 6, 9, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]
    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.


Enrollment: 566
Study Start Date: May 2006
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086033

  Show 60 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Thanasis Floros, MD AbbVie Pharmaceuticals S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01086033     History of Changes
Other Study ID Numbers: PMOS GREC 2004 06
Study First Received: February 26, 2010
Results First Received: July 17, 2013
Last Updated: September 24, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by AbbVie:
Evaluation of safety and efficacy
Adalimumab treatment
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014