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

Overview

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.

Full Title of Study: “Special Investigation in Japanese Rheumatoid Arthritis Patients Who Have no Previous Use of DMARDs and Biological Agents”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2015

Detailed Description

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.

Arms, Groups and Cohorts

  • Participants with high rheumatoid arthritis disease activity
    • Participants who received adalimumab treatment

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Adverse Events
    • Time Frame: From baseline through week 26
    • An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.

Secondary Measures

  • Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline
    • Time Frame: at week 0
    • The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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.
  • Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4
    • Time Frame: at week 4
    • The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 .
  • Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12
    • Time Frame: at week 12
    • The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 .
  • Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24
    • Time Frame: at week 24
    • The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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.
  • Percentage of Participants Achieving DAS28-4(ESR) Remission
    • Time Frame: From baseline to 24 weeks
    • The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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. The percentage of participants with a DAS28 score <2.6 was documented.
  • Mean Clinical Disease Activity Index (CDAI) Score at Baseline
    • Time Frame: at week 0
    • The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
  • Mean Clinical Disease Activity Index (CDAI) Score at Week 4
    • Time Frame: at week 4
    • The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
  • Mean Clinical Disease Activity Index (CDAI) Score at Week 12
    • Time Frame: at week 12
    • The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
  • Mean Clinical Disease Activity Index (CDAI) Score at Week 24
    • Time Frame: at week 24
    • The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
  • Percentage of Participants Achieving CDAI Remission
    • Time Frame: From baseline to 24 weeks
    • The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. The percentage of participants with a CDAI score ≤2.8 was documented.
  • Mean Simplified Disease Activity Index (SDAI) Score at Baseline
    • Time Frame: at week 0
    • The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
  • Mean Simplified Disease Activity Index (SDAI) Score at Week 4
    • Time Frame: at week 4
    • The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
  • Mean Simplified Disease Activity Index (SDAI) Score at Week 12
    • Time Frame: at week 12
    • The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
  • Mean Simplified Disease Activity Index (SDAI) Score at Week 24
    • Time Frame: at week 24
    • The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
  • Percentage of Participants Achieving SDAI Remission
    • Time Frame: From baseline to 24 weeks
    • The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. The percentage of participants with an SDAI score ≤3.3 was documented.

Participating in This Clinical Trial

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

Exclusion Criteria

There were no specific exclusion criteria.

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sarina Kurimoto, MD, Study Director, AbbVie GK

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