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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT02359903
Date of registration:	30/01/2015
Prospective Registration:	Yes
Primary sponsor:	Biocad
Public title:	Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Scientific title:	International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Date of first enrolment:	February 2015
Target sample size:	90
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02359903
Study type:	Interventional
Study design:
Phase:	Phase 1

Countries of recruitment
Belarus	Russian Federation

Contacts

Name:	Ivanov Roman, PhD
Address:
Telephone:
Email:
Affiliation:	JCS BIOCAD

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Infliximab (Remicade)

Drug: Infliximab (BCD-055)

Primary Outcome(s)

Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade [Time Frame: 2 weeks]

Secondary Outcome(s)

Mean Change of BASMI Score Compared With Baseline [Time Frame: 14 weeks / 30 weeks]

Percentage of Patients in Each Group Achieving ASAS40 [Time Frame: 14 weeks / 30 weeks]

Average Concentration of Infliximab at Steady State Phase [Time Frame: 28 weeks]

Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade [Time Frame: 2 weeks]

Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade [Time Frame: 28 weeks]

Mean Change of Chest Expansion Compared With Baseline [Time Frame: 14 weeks / 30 weeks]

Mean Change of SF36 Score Compared With Baseline [Time Frame: 14 weeks / 30 weeks]

Percentage of Patients in Each Group Achieving ASAS20 [Time Frame: 14 weeks / 30 weeks]

Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected [Time Frame: screening / 14 weeks / 30 weeks]

Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade [Time Frame: 2 weeks]

Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade [Time Frame: 28 weeks]

Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade [Time Frame: 2 weeks / 28 weeks]

Mean Change of MASES Score Compared With Baseline [Time Frame: 14 weeks / 30 weeks]

Mean Change of BASDAI Score Compared With Baseline [Time Frame: 14 weeks / 30 weeks]

Frequency of Early Withdrawal Due to AE/SAE [Time Frame: 30 weeks]

Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade [Time Frame: 2 weeks]

Mean Change of BASFI Score Compared With Baseline [Time Frame: 14 weeks / 30 weeks]

Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade [Time Frame: 28 weeks]

Total Frequency of AE/SAE Within the Whole Time of the Study [Time Frame: 30 weeks]

Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study [Time Frame: 30 weeks]

Secondary ID(s)

BCD-055-1/ASART-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	08/06/2016
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02359903

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