Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

NCT ID: NCT01114880

Last Updated: 2011-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-02-28

Brief Summary

Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Detailed Description

Adults with active ankylosing spondylitis (AS) were randomized in a 2:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or matching placebo, given subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could enter the 12-week open-label (OL) phase, during which all participants received treatment with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new adverse events (AEs).

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; China

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.

Group Type: PLACEBO_COMPARATOR

adalimumab

Intervention Type: BIOLOGICAL

Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week

placebo

Intervention Type: OTHER

Prefilled syringe, matching placebo administered subcutaneously every other week

Adalimumab

Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week

Interventions

adalimumab

Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week

Intervention Type: BIOLOGICAL

placebo

Prefilled syringe, matching placebo administered subcutaneously every other week

Intervention Type: OTHER

Other Intervention Names

ABT-D2E7; Humira

Eligibility Criteria

Inclusion Criteria

• Age 18 through 65 years
• Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria
• Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits:

• BASDAI score at least 4 cm
• Total back pain on a visual analog scale (VAS) at least 40 mm
• Morning stiffness at least 1 hr
• Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator

Exclusion Criteria

• Has total spinal ankylosis (bamboo spine)
• Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to Baseline
• Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel disease) that is not clinically stable, as defined by the Investigator's best clinical judgment, for at least 28 days prior to Baseline
• Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
• Has prior exposure to any biologic therapy with potential therapeutic impact on AS, including anti-TNF (tumor necrosis factor) therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aileen Pangan

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 24054

Hefei, AN, China

Site Reference ID/Investigator# 25522

Beijing, , China

Site Reference ID/Investigator# 24055

Beijing, , China

Site Reference ID/Investigator# 24052

Beijing, , China

Site Reference ID/Investigator# 24056

Guangzhou, , China

Site Reference ID/Investigator# 24243

Hangzhou, , China

Site Reference ID/Investigator# 24053

Shanghai, , China

Site Reference ID/Investigator# 24058

Shanghai, , China

Site Reference ID/Investigator# 24057

Xi'an, , China

Countries

China

Other Identifiers

M11-991

Identifier Type: -

Identifier Source: org_study_id