Rheumatoid Arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : methotrexate
INN of investigational material : methotrexate
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration
Sponsors
medac GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with no history of treatment with MTX by any route of administration (Part 1 only). 2.Subjects with a diagnosis of RA based on the 2010 EULAR/ACR criteria and have less than 2 year of disease duration (from diagnosis to the Screening Visit). 3.Subjects with a moderate or severe disease activity (DAS28 ESR >= 3.2) at the Screening Visit and the Baseline Visit. 4.Subjects with >= 4 tender joints and >= 4 swollen joints at the Screening Visit and the Baseline Visit (Part 1 only).
Exclusion criteria
Exclusion criteria: 1.Female subjects of childbearing potential and not practicing an appropriate method of birth control during the trial. 2.Male subjects, if fertile and sexually active, must agree to use highly effective methods of contraception if their female partners are of childbearing potential starting at the Screening Visit, throughout the entire trial period, and for at least 6 months after the final investigational product administration. 3.Subjects who are positive for the human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and / or the hepatitis B core antibody (HBcAb), hepatitis C antibody test at the Screening Visit. 4.Subjects with pulmonary tuberculosis (TB) or atypical mycobacterial infection, subjects with other serious infections (including sepsis, abscess, or opportunistic infection, or deep mycosis such as histoplasmosis) 5.Subjects with a strongly suspected previous TB infection by a positive or repeated indeterminate test result for interferon-gamma release assay (IGRA) at the Screening Visit. 6.Considered ineligible by the investigator or co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy ACR20 response at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -ACR20 response at Trial Weeks 4 and 8. -DAS28 ESR and proportion of subjects in the DAS28 ESR disease activity categories (remission, low, moderate, and high) at Trial Weeks 4, 8, and 12. -response at Trial Weeks 24, 36, 52, and 64. -DAS28 ESR and proportion of subjects in the DAS28 ESR disease activity categories (remission, low, moderate, and high) at Trial Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64. -Incidence of DDs, AEs, adverse device effects (ADEs), serious AEs (SAEs), or serious ADEs (SADEs) | — |
Countries
Japan
Outcome results
None listed