Arthritis Clinical Trials

Inclusion criteria:

Healthy Volunteers (HVs) in Part 1:

1. Healthy males and females according to the investigator¿s assessment (females of child-bearing potential must be using effective contraception)
2. Age 18 - 60 years
3. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Rheumatoid Arthritis (RA) patients in Part 2:

1. Age 18 - 70 years
2. Classified as having RA according to the 1987 American College of Rheumatology (ACR) Classification Criteria
3. <5 years from RA diagnosis to screening
4. Inadequate clinical response to methotrexate (MTX) monotherapy defined as moderate/high active disease after oral or subcutaneous (s.c.) MTX treatment given continuously for at least 3 months and for the last 6 weeks before screening at a stable weekly dose >15mg.
5. DAS28 4v-CRP >3.5 with >6 tender and >6 swollen joints at screening and confirmed by >6 tender and >6 swollen joints at randomisation visit (Visit 2)
6. Serum CRP level =1.0 mg/dL at screening
7. Anti-CCP2 positivity according to the limits of the assay used
8. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

Healthy Volunteers (HVs) in Part 1:

1. Any finding on clinical examination/history or laboratory value which deviates from normality and has clinical significance

Rheumatiod Arthritis (RA) pts in Part 2:

1. Current or previous use of an approved biologic agent 2. Current or previous participation in a clinical trial testing an investigational drug for RA 3. Disease activity score (DAS)28 < 3.2 in at least 2 occasions during the last 6 months before screening 4. Treatment with any standard disease modifying anti-rheumatic drug (DMARD) except methotrexate (MTX) continuing after randomisation 5. RA patients with severe disability (functional class IV) or with confirmed severe systemic manifestations 6. Impaired hepatic or renal function 8. Pre-existing blood dyscrasias 9. Hypersensitivity to MTX or any of its excipients 10. Previous intolerance to MTX as the main cause for stopping treatment (instead of lack of efficacy) 11. Any active or suspected malignancy or history of documented malignancy, except appropriately 12. Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical TB and/or a positive QuantiFERON TB-Gold test) treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.

13. Subject is assessed by the investigator as unsuitable for inclusion e.g. considered not able to understand and comply with study requirements or has a condition that would not allow safe participation in the study