Trials Sponsors Conditions Drugs Pricing

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

Assessment in SpondyloArthritis international Society (ASAS) 20
the percentage of subjects achieving the Assessment in SpondyloArthritis international Society (ASAS) 20 treatment response
week 12

Secondary Outcomes (16)

Percentage of subjects achieving ASAS20 treatment response
week 24
Percentage of subjects achieving ASAS40 treatment response
week 12; week 24
Percentage of subjects achieving ASAS5/6 treatment response
week 12; week 24
Percentage of subjects achieving BASDAI50 treatment response
week 12; week 24
Change of the performance status score compared with baseline
week 12; week 24
+11 more secondary outcomes

Study Arms (2)

BAT1406

EXPERIMENTAL

Adalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.

Drug: BAT1406

Humira

ACTIVE COMPARATOR

Adalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.

Drug: Humira

Interventions

BAT1406Drug

40mg/0.8ml

Also known as: No Other Intervention Names

BAT1406

HumiraDrug

40mg/0.8ml

Also known as: Adalimumab

Humira

Eligibility Criteria

Age16 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

Subjects have used any biological products to treat AS within 6 months prior to the enrollment.
Clinical or imaging studies suggested that the spine has reached complete rigidity (if there were two consecutive lumbar vertebrae not fused together, then the spine has not reached complete rigidity).

Sponsors & Collaborators

Bio-Thera Solutions
Industrylead

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized

Study Officials

Jieruo Gu, Doctor
Third Affiliated Hospital, Sun Yat-Sen University
PRINCIPAL INVESTIGATOR

Enrollment

554 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 22, 2019

Study Start

December 13, 2016

Actual (reported)

A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (2)

BAT1406

Humira

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (2)

BAT1406

Humira

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record