Inclusion Criteria:
For patients suffering from rheumatoid arthritis:
- rheumatoid arthritis diagnosed based on The American Rheumatism Association Criteria from 1987
- ineffective treatment with 2 disease-modifying antirheumatic drugs (DMARDs) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment)
- high disease activity - Disease Activity Score 28 (DAS 28) > 5,1 measured twice, with a 1-month interval
- for patients with mainly lower limbs affected with DAS 28 > 3,7
For patients suffering from Ankylosing Spondylitis:
- Ankylosing Spondylitis diagnosed based on Modified New York Criteria
- ineffective treatment with 2 non-steroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months
- high disease activity -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4 measured twice, with a 12-week interval
- spinal pain > 4cm on 10cm Visual Analogue Scale (VAS) measured twice, with a 12-week interval
- general disease activity assessment > 5 (0-10 scale) performed after the 2nd VAS and BASDAI assessment
For patients suffering from Psoriatic Arthritis:
- Psoriatic arthritis diagnosed based on the Bennett or Classification Criteria for Psoriatic Arthritis (CASPAR Criteria)
If peripheral joints are affected:
active disease assessed twice, with a 4-week interval on stable treatment, after 2 DMARDs treatment for at least 4 months
Criteria of active disease (all have to be met):
- At least 5 out of 66 joints swollen - assessed twice, with a 4-week interval
- At least 5 out of 68 joints tender - assessed twice, with a 4-week interval
- general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by patient
- general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by physician
- general disease activity assessment > 5 (0-10 scale) performed after 2nd assessment of number of tender and swollen joints
If axial joints are affected:
- Sacroiliac joints affected according to the New York Criteria of Ankylosing Spondylitis
- Active and severe disease assessed twice, with a 12-week interval, stable treatment, ineffective treatment with 2 nonsteroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months each
Criteria of active disease (all must be present):
- BASDAI > 4 measured twice, with a 12-week interval
- spinal pain > 4cm on 10 cm in the VAS measured twice, with a 12-week interval
- general disease activity assessment > 5 (0-10 scale) Patients can take steroid in stable dose within one month - maximal dose 10mg/day of prednisone.
Exclusion Criteria:
- non-consenting patient
- pregnancy
- breast-feeding
- allergy for the drug or any component
- cardiac insufficiency (NYHA III or IV)
- active infection
- infection within the last 3 months: hepatitis, pneumonia, pyelonephritis
- opportunistic infection within the last 2 months: active infection of cytomegalovirus, Pneumocystis carinii
- joint infection within the last 12 months
- endoprosthesis infection within the last 12 months or any time if the joint was not replaced
- exacerbation of lung-, kidney-, liver- or heart insufficiency during treatment
- demyelinating disease or its symptoms
- pancytopenia or aplastic anemia
- pre-cancer stage
- neoplasm within the last 5 years including solid tumors and neoplasm of haematopoietic or lymphatic system with risk of recurrence or progression
- active alcoholic disease
- chronic liver disease