Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SynAct Pharma Aps
With
NBCD A/S
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
Candidate for MTX treatment
Is about to begin treatment with MTX
Must meet at least one of the following parameters at Screening:
1. positive result for anti-CCP or RF
2. Serum CRP ≥ 6 mg/L
Highly active RA (CDAI \> 22) at screening and baseline
Negative QuantiFERON-in-Tube test (QFG-IT)
Females of child-bearing potential must use of highly effective birth control method
You may not be if
Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable
Prior history of or current inflammatory joint disease other than RA
Subjects with fibromyalgia
Use of hydroxychloroquine within 4 weeks prior the Screening Visit
Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit
Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
Have prior renal transplant, current renal dialysis, or 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)
Neuropathies or other painful conditions that might interfere with pain evaluation
Body weight of \>150 kg
HBsAg positive and/or Anti-HBc with sign of current infection.
