Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Ankylosing Spondylitis

Treatments: Drug: Infliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01220518

CT-P13 1.1

Details and patient eligibility

About

This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.

Enrollment: 257 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with active ankylosing spondylitis
• BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4

Exclusion criteria

• have total ankylosing of spine
• have allergies to infliximab
• serious infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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257 participants in 2 patient groups

CT-P13

Active Comparator group

Description:

infliximab

Treatment:

Drug: Infliximab

Remicade

Active Comparator group

Description:

infliximab

Treatment:

Drug: Infliximab