Adalimumab has the indication for life-long treatment of RA but can adalimumab be discontinued in patients who are in stable clinical remission (DAS28<2.6) with retained low disease activity or will the RA symptoms relapse? If relapse occurs, how is the response if adalimumab is reinstituted? MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Injection
INN or Proposed INN: Adalimumab
Current Sponsor code: ABT-Humira
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Abbott Scandinavia AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject is of age ³ 18 years. 2) Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification and has a documented positive RF test or erosion on radiograph of hands or feet. 3) Subject is currently treated with adalimumab and MTX (at least 10 mg/week; orally or subcutaneously) and has received both for at least 6 months (MTX dose stable for at least 2 months). 4) Subject is in remission as defined by DAS28=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks. Inhaled corticosteroids for stable medical conditions are allowed. 2) Oral prednisone or prednisone equivalent > 10 mg/day at baseline. 3) Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study). 4) Subject has a history of acute inflammatory joint disease of different origin other than RA (e.g., mixed connective tissue disease, seronegative spondyloarthritis, psoriatic arthritis, Reiter's syndrome, fibromyalgia, systemic lupus erythematosus or any arthritis with onset prior to age 17 years). 5) Subject has been treated with any investigational drug within 30 days or 5 half lives – whichever is longer prior to study entry (baseline visit). 6) Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate to severe congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study. 7) Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis). 8) Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease. 9) Subject has history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. 10) Subject has a history of listeriosis, histoplasmosis, untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous (IV) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit. 11) Subject is known to have immune deficiency, history of HIV or is immunocompromised. 12) Female subject who is pregnant or breast-feeding or considering becoming pregnant or breast feeding during the study or for 150 days after the last dose of study medication. 13) Subject has a history of clinically significant drug or alcohol usage in the last year or cannot maintain an alcohol intake of 30 g a day or less throughout the study. One standard drink is defined as 180 mL/6 oz (approx. 10 g) of wine, 360 mL/12 oz (approx. 15 g) of regular beer, or 45 mL/1.5 oz (approx. 10 g) of spirits. 14) Baseline clinical laboratory analyses show any of the following abnormal laboratory results: ? Aspartate transaminase (AST) or alanine transaminase (ALT) >1.5x the upper limit of normal (ULN). ? Serum total bilirubin ³ 1.5 mg/dL (³26 micromol/L). ? Creatinine > 1.5 mg/dL (133 micromol/L) in subjects upper limit of normal range in subjects ³ 65. ? Evidence of chronic Hepatitis B or C serology indicative of previous or current infection. 15) Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 16) Subjects with any prior exposure to Tysabri (natalizumab). 17) Subjects with known hypersensitivity to the excip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the proportion patients with RA in stabel clinical remission (DAS28<2.6) after treatment with adalimumab in combination with methotrexate in whom it is possible to discontinue adalimumab treatment without an increase in disease activity.;Secondary Objective: To study the frequency of flare after adalimumab discontinuation and to study the effect of reinstitution of adalimumab after flare. To study the safety of adalimumab in reinstitution of therapy;Primary end point(s): The proportion of RA patients in clinical remission whom is possible to discontinue adalimumab without an increase in disease activity at 28 weeks. | — |
Countries
Sweden
Outcome results
None listed