Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"

Sponsor
Fen Li
Study ID
NCT02878161
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • methotrexate(necessary) — DRUG
    Methotrexate will be received orally with dosage of 10mg/ week for every patient and MTX dose must be stable for at least 4 weeks.
  • infliximab — BIOLOGICAL
    infliximab :intravenous injection 200mg,every times,0,2,6,14week ,4 times)
  • etanercept — BIOLOGICAL
    Etanercept :hypodermic injection,25mg/twice a week
  • adalimumab — BIOLOGICAL
    Adalimumab:hypodermic injection,40mg/twice a week
  • leflunomide (permitted, not necessary) — DRUG
    LEF will be permitted if patient had received for 1 month before enrollment and will not be changed for 14 weeks.
  • NSAIDs (permitted,not necessary) — DRUG
    NSAIDs will be allowed if patient had received for 1 month before enrollment and will not be changed for 14 weeks.
  • Glucocorticoids (permitted,not necessary) — DRUG
    Glucocorticoids (prednisone less than 10mg/day, or equal dosage of other similar drugs) will be permitted if the patient had received for 1 month before enrollment and the dosage will not be changed during the period.

Study Details

Rheumatoid arthritis (RA) is a chronic and disabling disease. tumor necrosis factor-a(TNF-a) inhibitors have demonstrated an outstanding performance in relieving joint inflammation and retarding bone erosion involved in RA. However, there is still about one-thirds of RA patients had a poor response to TNF α inhibitors. The Investigators hope to discover prediction protein with a domestic genetic background and finally establish prediction system with Chinese characteristics.

Key Dates

Start date
Jan 31, 2016
Status verified
Jul 2016
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: A group
    Infliximab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.
  • Experimental: B group
    Etanercept plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.
  • Experimental: C group
    Adalimumab plus Methotrexate , Leflunomide and NSAIDs and Glucocorticoids are permitted but not necessary included.

Primary Outcome Measure

EULAR (European League Against Rheumatism) response will be assessed among patients of 3 groups [ Time Frame: Baseline, Weeks 14 ]

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