A Dose-range Study of the Safety and Efficacy of Treatment in Adult Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate (RESOLVE)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III ≥6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) Must meet at least one of the following parameters at Screening: A positive result for Anti-Cyclic Citrullinated Peptide (anti-CCP) or Rheumatoid Factor (RF), Serum CRP ≥ 6 mg/L based on central laboratory value Ongoing methotrexate therapy ≥12 weeks in a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to the baseline visit Subject has an inadequate clinical response to maximally tolerated methotrexate therapy Subjects should be receiving an adequate and prescribed stable dose of folic acid (≥5 mg/week total dose or as per local clinical practice) which should be confirmed or initiated at screening and continued throughout the study Negative QuantiFERON-in-Tube test (QFG-IT) Females of child-bearing potential must use of highly effective birth control method Male participant's partner must use highly effective birth control Exclusion Criteria: Use of all other biologic or nonbiologic DMARDs and immunosuppressive therapy within 4 weeks prior to administration of the first dose of study drug Oral steroids at a dose >10 mg/day of prednisone or a prescription for oral steroids which has changed within 4 weeks of baseline Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to baseline Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within the period of the study participation Rheumatic autoimmune disease other than RA Functional class IV as defined by the ACR Criteria for Classification of Functional Status in RA or wheelchair/bedbound Prior history of or current inflammatory joint disease other than RA Subjects with fibromyalgia Initiation or change in dose for NSAIDs (including low-dose aspirin and Cyclooxygenase (COX-2) inhibitors) within 2 weeks prior to baseline Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease Serum Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 1.5 x the upper limit of normal (ULN) and alkaline phosphatase (ALP) and/or bilirubin values above the ULN at the screening visit Have prior renal transplant, current renal dialysis, or moderate to severe renal insufficiency Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured) History of alcohol, drug, or chemical abuse within the 6 months prior to screening Neuropathy or other painful, chronic conditions that might interfere with pain evaluation Body weight of >150 kg HBsAg positive and/or Anti-HBc with sign of current infection.
Sites / Locations
- Timofei Mosneaga Republican Clinical HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
AP1189, 60 mg
AP1189, 80 mg
AP1189, 100 mg
Placebo
Part A: (AP1189, 60 mg); Part B: (TBD)
Part A: (AP1189, 80 mg); Part B: (TBD)
Part A: (AP1189, 100 mg); Part B: (TBD)
Part A: (placebo); Part B: (placebo).