Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02132234
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02132234
Study Brief:
Protocol Section:
NCT02132234