Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis (AGIL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01076205
First received: February 24, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The primary objective of the study is to explore the therapeutic success, measured by improvements in the following variables :

- The number of missed working days

The secondary objective is to document the therapeutic success by the following variables:

  • The number of physician visits
  • The number and duration of hospitalization
  • The number of days of impairment in non-occupational activities
  • The duration of morning stiffness, pain, exhaustion/fatigue

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long Term Documentation of the Safety and Efficacy as Well as the Effects on Quality of Life and Work Productivity in Patients With Rheumatoid Arthritis Under HUMIRA® (Adalimumab) in Routine Clinical Practice (AGIL)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of missed working days; self assessed workability; severity of clinical symptoms (number of tender and swollen joints), C-reactive Protein; severity of functional impairment; assessment of quality of life. Safety: Analysis of adverse events. [ Time Frame: 0, 3, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number and duration of hospitalization; number of days of impairment of non-professional activities; self-assessment of therapy in comparison to previous therapies. [ Time Frame: 0, 3, 6, 12, 24, 36, 48, 60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4500
Study Start Date: January 2009
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with rheumatoid arthritis
Patients with moderate to severe active rheumatoid arthritis.

Detailed Description:

The primary objective of the study is to explore the therapeutic success, measured by improvements in the target variables:

  • The number of missed working days
  • The self-assessed work ability (modified WAI)
  • The severity of clinical symptoms (number of tender and swollen joints, C-reactive Protein and Erythrocyte Sedimentation Rate, respectively; Disease Activity Score 28)
  • The severity of functional impairment (Health Assessment Questionnaire)
  • The health-related quality of life. All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.

The secondary objective is to document the therapeutic success by the following variables:

  • The number of physician visit
  • The number and duration of hospitalization
  • The number of days of impairment in non-occupational activities
  • The duration of morning stiffness, pain, exhaustion/fatigue.
  • The reduction of number and dose of concomitant medication
  • Patient assessment of adalimumab therapy compared to previous therapies.

Target parameters for safety evaluation of adalimumab are:

  • The evaluation of safety and tolerability by the documentation and analysis of serious adverse events (SAEs) and adverse events (AEs)
  • Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases, especially diabetes type II, cardiovascular, liver, and renal insufficiencies, and related concomitant medications.
  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

Community sample: Patients with rheumatoid arthritis

Criteria

Inclusion Criteria:

  • Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs
  • Inclusive methotrexate
  • Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before In case of incompatibility with methotrexate, Humira can be used as monotherapy.

Exclusion Criteria:

  • Hypersensitivity against the drug or one of the other ingredients
  • Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
  • Moderate to severe cardiac insufficiency
  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: NCT01076205

Contacts
Contact: Gerd Greger, PhD +49 6122 58-1610 gerd.greger@abbvie.com
Contact: Elisabeth Glaser-Caldow 49 6122 581235 elisabeth.glaser@abbvie.com

  Show 393 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01076205     History of Changes
Other Study ID Numbers: P11-973
Study First Received: February 24, 2010
Last Updated: April 10, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Humira
Long-term Observation
Quality of Life
Work Productivity
Rheumatoid Arthritis

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

ClinicalTrials.gov processed this record on July 20, 2014