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NCT Number: NCT03264703

Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World

This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).

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Key information

Conditions

Arthritis, Rheumatoid Arthralgia Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Trial Site # 1, Ilsan, Gyeonggi-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with rheumatoid arthritis within 3 years
  • Participants who have no experience with anti-tumor necrosis factor (anti-TNF)
  • Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent
  • Participants who change the treatment regimen to one of the following according to the opinion of the investigator:
  • One cDMARD plus anti-TNF
  • Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent

Exclusion criteria

  • Participants who may be pregnant or lactating women
  • Participants who have contraindication to anti-TNF
  • Participants who had participated in this study

Treatment and study plan

Primary outcomes

  1. Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6

    Time frame: Baseline; Month 6

    DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.

Secondary outcomes

  1. Change from Baseline in the DAS28-ESR at Month 3

    Time frame: Baseline; Month 3

    DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.

  2. Change from Baseline in the DAS28-ESR at Month 12

    Time frame: Baseline; Month 12

    DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.

  3. Clinical remission rate measured by DAS28-ESR

    Time frame: Up to 12 months

    Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.

  4. Success rates of dose-reduction and discontinuation of steroid(s)

    Time frame: Up to 12 months

    Dose reduction is defined as a reduction by more than 50% compared to baseline.

  5. Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life

    Time frame: Up to 12 months

    The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World ["HUMAN" Study]

Acronym: HUMAN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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