Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163318
First received: July 14, 2010
Last updated: May 28, 2015
Last verified: May 2015
  Purpose

The purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the drug for the treatment of rheumatoid arthritis.


Condition
Rheumatoid Arthritis

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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: From the initiation of adalimumab treatment, every 6 months up to 3 years. ] [ Designated as safety issue: Yes ]
    An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.


Secondary Outcome Measures:
  • Incidence of Infections and Malignant Tumors [ Time Frame: From the initiation of adalimumab treatment, every 6 months up to 3 years. ] [ Designated as safety issue: Yes ]
    Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.

  • Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit [ Time Frame: Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3 ] [ Designated as safety issue: No ]
    DAS28-4ESR, a combined index that measured activity of rheumatoid arthritis, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); and (4) ESR. DAS28-4ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28-4ESR scores indicate improvement of disease. DAS28-4ESR score < 2.6 was defined as clinical remission of rheumatoid arthritis. Data are presented as percentage of participants.

  • Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit [ Time Frame: Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3 ] [ Designated as safety issue: No ]
    MHAQ was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatic diseases. Participants assessed their ability to do each task over the past 6 months using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0 represented no disability and 3 very severe, high-dependency disability. MHAQ score ≤ 0.5 was defined as clinical remission, signifying normal physical function. Data are presented as percentage of participants.


Enrollment: 552
Study Start Date: December 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab 40 mg/0.8 mL syringe for subcutaneous injection
Participants with rheumatoid arthritis who received adalimumab, per approved label

Detailed Description:

Rheumatoid arthritis is a chronic autoimmune disease which requires long-term treatment. Due to the need of long-term safety data in Japanese participants and to fulfil the conditions of approval of adalimumab by the Japanese regulatory authority, this post-marketing observational study (PMOS) was conducted. The study investigated the long-term safety of adalimumab, particularly associated with the development of infections and malignant tumors. Data was collected once every 6 months up to 3 years.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.

Criteria

Inclusion criteria:

  1. Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.
  2. Participants who used adalimumab continuously.
  3. Participants without current or past history of malignant tumors.
  4. Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR).
  5. Participants evaluated by Health Assessment Questionnaire (HAQ) or Modified Health Assessment Questionnaire (MHAQ) prior to the initiation of adalimumab treatment in the all-case PMOS.

Exclusion criteria:

  1. Contraindications according to the package insert.
  2. Participants with serious infections.
  3. Participants with tuberculosis.
  4. Participants with a history of hypersensitivity to any ingredient of adalimumab.
  5. Participants with demyelinating disease or a history of demyelinating disease.
  6. Participants with congestive cardiac failure.
  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: NCT01163318

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sarina Kurimoto AbbVie GK
  More Information

Additional Information:
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
Results First Received: May 28, 2015
Last Updated: May 28, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Rheumatoid Arthritis

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

ClinicalTrials.gov processed this record on July 27, 2015