Trial Outcomes & Findings for Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis (NCT NCT02359903)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

90 participants

Primary outcome timeframe

2 weeks

Results posted on

2016-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	BCD-055 Group BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha	Remicade Group Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (Remicade)
Overall Study STARTED	45	45
Overall Study COMPLETED	45	43
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	BCD-055 Group BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha	Remicade Group Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (Remicade)
Overall Study Adverse Event	0	2

Baseline Characteristics

Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BCD-055 Group n=45 Participants BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha	Remicade Group n=45 Participants Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (Remicade)	Total n=90 Participants Total of all reporting groups
Age, Continuous	38 years n=5 Participants	38 years n=7 Participants	38 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.

Outcome measures

Outcome measures
Measure	BCD-055 Group n=44 Participants BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha	Remicade Group n=43 Participants Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (Remicade)
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade	26282582 (ng/ml)*hour Interval 21094742.0 to 32296361.0	25914888 (ng/ml)*hour Interval 20105020.0 to 32661812.0

SECONDARY outcome

Timeframe: 2 weeks

Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.

Outcome measures

Outcome measures
Measure	BCD-055 Group n=44 Participants BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha	Remicade Group n=43 Participants Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Infliximab (Remicade)
Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade	174638 ng/ml Interval 139415.0 to 239141.0	195434 ng/ml Interval 134622.0 to 257656.0

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks / 28 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 weeks