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

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]

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03264703

Acronym

HUMAN

Enrollment

212

Registered

2017-08-29

Start date

2017-09-11

Completion date

2019-07-17

Last updated

2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Joint pain, Joint stiffness, Joint redness, Loss of joint function, Swollen joints

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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: 1. One cDMARD plus anti-TNF 2. 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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6	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

Measure	Time frame	Description
Change from Baseline in the DAS28-ESR at Month 3	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.
Change from Baseline in the DAS28-ESR at Month 12	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.
Clinical remission rate measured by DAS28-ESR	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.
Success rates of dose-reduction and discontinuation of steroid(s)	Up to 12 months	Dose reduction is defined as a reduction by more than 50% compared to baseline.
Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life	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.

Countries

South Korea

Outcome results