Phase 1
Completed N=90
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT02359903 ↗Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Jun 2016
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade — 26282582; 25914888 (ng/ml)*hour
Summary
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade |
26282582; 25914888 | — |
| SECONDARY Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade |
174638; 195434 | — |
| SECONDARY Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade |
— | — |
| SECONDARY Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade |
— | — |
| SECONDARY Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade |
— | — |
| SECONDARY Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade |
— | — |
| SECONDARY Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade |
— | — |
| SECONDARY Average Concentration of Infliximab at Steady State Phase |
— | — |
| SECONDARY Percentage of Patients in Each Group Achieving ASAS20 |
— | — |
| SECONDARY Percentage of Patients in Each Group Achieving ASAS40 |
— | — |
| SECONDARY Mean Change of BASDAI Score Compared With Baseline |
— | — |
| SECONDARY Mean Change of BASMI Score Compared With Baseline |
— | — |
| SECONDARY Mean Change of BASFI Score Compared With Baseline |
— | — |
| SECONDARY Mean Change of MASES Score Compared With Baseline |
— | — |
| SECONDARY Mean Change of SF36 Score Compared With Baseline |
— | — |
| SECONDARY Mean Change of Chest Expansion Compared With Baseline |
— | — |
| SECONDARY Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade |
— | — |
| SECONDARY Total Frequency of AE/SAE Within the Whole Time of the Study |
— | — |
| SECONDARY Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study |
— | — |
| SECONDARY Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected |
— | — |
| SECONDARY Frequency of Early Withdrawal Due to AE/SAE |
— | — |
Eligibility Criteria
Inclusion Criteria
- signed informed consent
- active ankylosing spondylitis, which exists in patient within last 3 months
- BASDAI score > or equal to 4 points, spinal pain (by VAS) > or equal to 4 points
- history of NSAID use for the treatment of AS within last 3 months
- adequate renal and liver function
- absence of severe abnormalities in complete blood count
- consent to use adequate contraception
- ability to follow Protocol procedures
Exclusion Criteria
- previously use of any biologic for AS treatment
- total ankylosing of the spine
- known allergy to chimeric proteins or any excipients of BCD-055/Remicade
- hepatitis B, active hepatitis C, HIV, syphilis
- known tuberculosis
- latent forms of tuberculosis
- any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks)
- drug or alcohol abuse
- any other disease which can affect assessments or masking some symptoms of AS (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from AS, etc.)
- severe uncontrolled hypertension
- chronic heart failure
- decompensated renal or liver disorders
- severe uncontrolled diabetes mellitus
- chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis
- any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis
- unstable angina pectoris
- myocardial infarction within last 12 months
Other exclusion criteria could be found in the Full Study Protocol
Data sourced from ClinicalTrials.gov (NCT02359903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.