Ankylosing Spondylitis
Conditions
Brief summary
BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in patients with ankylosing spondylitis. BCD-055 is biosimilar of infliximab (JSC BIOCAD, Russia)
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening. * Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening. * Mean backache intensity equals 4 points or more.
Exclusion criteria
* Previous therapy of ankylosing spondylitis with monoclonal antibodies (including tumor necrosis factor) * Total spinal ankylosis * History of tuberculosis * Body mass more than 120 kg * Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent. * Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization. * Prior use of alkylating agents for up to 12 months prior to signing informed consent. * Intraarticular use of corticosteroids for up to 4 weeks before randomization. * Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of patients with ASAS20 response after 30 weeks of therapy | Week 30 | Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 30 weeks of therapy with BCD-055. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more after 14, 30 and 54 weeks of therapy with BCD-055. |
| Mean change in BASDAI after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) after 14, 30 and 54 weeks of therapy |
| Mean change in BASMI after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Mean change in Bath Ankylosing Spondylitis Metrology Index (BASMI), after 14, 30 and 54 weeks of therapy |
| Mean change in BASFI after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Mean change in Bath Ankylosing Spondylitis Functional Index (BASFI) after 14, 30 and 54 weeks of therapy |
| Mean change in MASES after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Mean change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) after 14, 30 and 54 weeks of therapy |
| Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy | Week 14, Week 54 | Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 14 and 54 weeks of therapy with BCD-055. |
| Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy |
| Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy |
| Frequency of AE/SAE | 54 weeks | Frequency of AE/SAE |
| Frequency of AE 3-4 grade CTCAE | 54 weeks | Frequency of AE 3-4 grade CTCAE |
| Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | Mean score of quality of life as assessed by Short Form-36 (SF-36) at screening and after 14, 30 and 54 weeks of therapy |
Countries
Russia
Outcome results
None listed