Clinical trial NCT02762812: Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Ratio of patients with ASAS20 response after 30 weeks of therapy
timeFrame: Week 30
Secondary outcomes:
measure: Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy
timeFrame: Week 14, Week 54
measure: Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean change in BASDAI after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean change in BASMI after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean change in BASFI after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean change in MASES after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
timeFrame: Week 14, Week 30, Week 54
measure: Frequency of AE/SAE
timeFrame: 54 weeks
measure: Frequency of AE 3-4 grade CTCAE
timeFrame: 54 weeks
Other outcomes:
Locations:
city: St.Petersburg
country: Russian Federation
facility: North-Western State Medical University n.a. I.I.Mechnikov
Study officials:
affiliation: JCS BIOCAD
name: Roman Ivanov, PhD
role: STUDY_CHAIR
References: