Special Investigation of Humira on Long-term Treatment in Patients With Rheumatoid Arthritis - Full Text View

Purpose

The present survey will be conducted to collect information on the safety (especially the development of malignant tumors, infections, and other untoward events) and effectiveness of Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection (Humira) in patients receiving the drug for a long period of time for the treatment of rheumatoid arthritis, for the purpose of investigating and confirming factors affecting the safety and effectiveness of the drug.

Condition
Rheumatoid Arthritis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Special Investigation on Long-term Treatment in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Evaluation of adverse event [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
Evaluation of adverse event [ Time Frame: at 1.5 years ] [ Designated as safety issue: Yes ]
Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
Evaluation of adverse event [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
Evaluation of adverse event [ Time Frame: at 2.5 years ] [ Designated as safety issue: Yes ]
Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
Evaluation of adverse event [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 1.5 years ] [ Designated as safety issue: No ]
Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 2.5 years ] [ Designated as safety issue: No ]
Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
Modified Health Assessment Questionnaire [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
Modified Health Assessment Questionnaire [ Time Frame: at 1.5 years ] [ Designated as safety issue: No ]
Modified Health Assessment Questionnaire [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
Modified Health Assessment Questionnaire [ Time Frame: at 2.5 years ] [ Designated as safety issue: No ]
Modified Health Assessment Questionnaire [ Time Frame: at 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Humira Those with an exposure

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Those who are receiving Humira in accordance with its indications for treatment and dosage regimens

Criteria

Inclusion Criteria:

Those who are receiving Humira in accordance with its indications for treatment and dosage regimens
Those who are using Humira continuously
Those with no current and no past history of malignant tumor
Those evaluable for Disease Activity Score28-4erythrocyte sedimentation rate
Patients who have been evaluated by Health Assessment Questionnaire or Modified Health Assessment Questionnaire prior to initiation of Humira treatment (prior to initial administration of Humira in the all-case survey)

Exclusion Criteria:

Contraindications according to the Package Insert
Patients who have serious infections
Patients who have tuberculosis
Patients with a history of hypersensitivity to any ingredient of Humira
Patients who have demyelinating disease or with a history of demyelinating disease
Patients who have cardiac failure congestive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163318

Show 122 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Toshiro Maeda

AbbVie GK

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01163318 History of Changes
Other Study ID Numbers:	P12-070
Study First Received:	July 14, 2010
Last Updated:	April 22, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:

Rheumatoid Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013