A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab; methotrexate
Intervention description: 40 mg every other week via subcutaneous injection; At least 10 mg/week administered orally or subcutaneously
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adalimumab,Remission,drug discontinuation

Summary:

      The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab
      therapy in patients with rheumatoid arthritis who are in stable remission after treatment
      with adalimumab in combination with methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years.

          -  Diagnosis of RA as defined by the 1987-revised American College of Rheumatology
             (ACR)-classification and has positive rheumatoid factor (RF) test or erosion on X-ray
             of hands or feet.

          -  Currently treated with adalimumab and MTX (at least 10 mg/week; orally or
             subcutaneously).

          -  In remission as defined by disease activity score (DAS)28 <2.6 for at least the past 3
             months.

          -  Concomitant disease-modifying anti-rheumatic drug (DMARD) or oral corticosteroid
             therapy has been stable for at least 3 months at study entry.

          -  Female subject is either not of childbearing potential or is practicing a relevant
             method of birth control.

          -  Subject is judged to be in good general health.

          -  Subjects must be able and willing to provide written informed consent.

          -  Subjects must be able and willing to self-administer subcutaneous (SC) injections or
             have a qualified person available to administer SC injections.

        Exclusion Criteria:

          -  Treatment with intra-articular or parenteral administration of corticosteroids in the
             preceding 4 weeks.

          -  Oral prednisone or prednisone equivalent > 10 mg/day at baseline.

          -  Joint surgery within the preceding two months.

          -  History of acute inflammatory joint disease other than RA.

          -  Treatment with any investigational drug within 30 days or 5 half lives, whichever is
             longer prior to study entry.

          -  Poorly controlled medical condition, which would put the subject at risk by
             participation in the study.

          -  History of clinically significant hematologic, renal or liver disease.

          -  Diagnosis of, or history suggestive of, central nervous system (CNS) demyelinating
             disease.

          -  History of cancer or lymphoproliferative disease other than a successfully treated
             non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma
             of the cervix.

          -  History of listeriosis, histoplasmosis, untreated tuberculosis (TB), persistent
             chronic infections, or recent active infections.

          -  Known immune deficiency or human immunodeficiency virus (HIV).

          -  Female who is pregnant or breast-feeding or considering becoming pregnant or breast
             feeding during the study.