Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-09-30

Brief Summary

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This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

Detailed Description

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This was a multicenter, prospective, observational study of adalimumab. Each participant enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until discontinuation of the drug.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with high rheumatoid arthritis disease activity

Participants who received adalimumab treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. High disease activity, with poor prognostic factors (e.g., rheumatoid factor \[RF\]-positive, anti-cyclic citrullinated peptide \[CCP\] antibody-positive, or bone erosion)
2. Combination of adalimumab and methotrexate will be started
3. No prior history of treatment with disease-modifying anti-rheumatic drugs
4. No prior history of treatment with biological agents
5. Adalimumab dosed according to the registered product label
6. Signed informed consent

Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarina Kurimoto, MD

Role: STUDY_DIRECTOR

AbbVie

Countries

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Japan

References

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Ito Y, Hozumi K, Okada Y, Kurimoto S. Adalimumab with Methotrexate in Treatment-Naive Japanese Patients with Rheumatoid Arthritis at Risk of Progressive Structural Joint Damage: A Postmarketing Observational Study. Rheumatol Ther. 2017 Jun;4(1):151-166. doi: 10.1007/s40744-017-0059-1. Epub 2017 Mar 31.

Reference Type DERIVED

PMID: 28364381 (View on PubMed)

Other Identifiers

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P13-983

Identifier Type: -

Identifier Source: org_study_id