Rheumatoid arthritis
Conditions
Interventions
No reduction group:Treatment of adalimumab
Extended cycle group, reduction group and drug withdrawal group:Treatment of adalimumab
Reduction group and drug withdrawal group:Treatment of adalimumab
Drug withdrawal group:Treatment of adalimumab
Sponsors
The Second Affiliated Hospital Of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subject is a man or woman, 18 to 70 years of age. 2.Diagnosis of rheumatoid arthritis (RA) according to the revised 1987 ACR or 2010 ACR /EULAR criteria for the classification of rheumatoid arthritis. 3.Subject receives adalimumab for at least 24 weeks at a recommended dose (40 mg subcutaneously every two weeks) and is in clinical remission (DAS28 < 2.6) or low disease activity (2.6=DAS28 =3.2) for at least 3 months in screening period. 4.Subject must be able and willing to provide written informed consent and to comply with the requirements of this study protocol and agree to use an effective form of contraception at the time of consent. 5.Subject has had regular use of MTX (with concomitant folic acid or not) for at least 12 weeks and take a stable dose of 7.5–25 mg per week within 4 weeks prior to enrollment. For subject who is intolerant of MTX, subject has had regular use of 10-20mg Leflunomide per day or 2-3g sulfasalazine per day. 6.Subject received the drugs with stable dosage for at least 2 weeks prior to the baseline (start of treatment) for RA treatment:Non-steroidal anti-inflammatory drugs (NSAIDs), opioid analgesics,or acetaminophen. 7.Subject received a stable dose(=10mg/day prednisone or equivalent dose of other glucocorticoids) for at least 4 weeks prior to enrollment if they are taking oral glucocorticoids in screening period.
Exclusion criteria
Exclusion criteria: 1. Subjects met any of the following criteria associated with latent or active tuberculosis (TB) infection: (1) A history of active tuberculosis within 3 years(Subjects with a history of active tuberculosis 3 years ago and adequate treatment can participate in the study); (2) Medical history and/or physical examination prompt active tuberculosis; (3) Close contact with someone with active TB recently; (4) Tuberculosis infection T cell detection is positive in the screening period. Subjects must be excluded if their first tuberculosis infection T cell detection result is inconclusive. Subjects with positive or uncertain results may be the exception handling, if they completed suitable standard treatment of latent TB and have no other risk factors, imaging signs, or supporting the latent or active TB prior to the screening visit. The investigator should determine the risk of tuberculosis (including extrapulmonary) with a qualified infectious physician and discuss the decision with the sponsor. 2. Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive; treponema pallidum antibody positive; 3. Any active or chronic systemic infection; 4. A history of malignancy; 5. Moderate or Severe heart failure (New York Heart Association Class III and IV) or severe, uncontrolled diseases of kidney, liver, blood, gastrointestinal, lung, cardiovascular, neurological or brain. The investigator consider that patients will be in unacceptable risk with participating in the study; 6. Females who are pregnant or breastfeeding; 7. A history of severe allergic reactions or anaphylaxis to monoclonal antibodies. Intolerance to ingredients of adalimumab; 8. Receipt of a live or attenuated vaccine within 8 weeks prior to the screening visit;(Separate instructions for COVID-19 vaccines) 9. Participation in another investigational study within 4 weeks prior to the screening visit or in 5 half lives; 10. Any other systemic autoimmune diseases as a comorbidity;(e.g. systemic lupus erythematosus, etc.) 11. Subjects considered by the investigator, for other reason, to be an unsuitable candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Low disease activity rate;Clinical remission rate; | — |
Countries
China
Contacts
Public ContactXinwang Duan
The Second Affiliated Hospital Of Nanchang University
Outcome results
None listed