Clinical Drug Experience Knowledgebase

Criteria

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