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

NCT01114880 | Completed Phase 3 Results

• 1 other identifier: M11-991
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 9

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)

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; China

Outcome Measures

Primary Outcomes (1)

• Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria

  ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).

  Week 12

Secondary Outcomes (21)

• Number of Participants Meeting the ASAS20 Response Criteria

  Week 24

• Number of Participants Meeting the ASAS40 Response Criteria

  Week 12

• Number of Participants Meeting the ASAS40 Response Criteria

  Week 24

• Number of Participants Meeting the ASAS5/6 Response Criteria

  Week 12

• Number of Participants Meeting the ASAS5/6 Response Criteria

  Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Biological: adalimumab; Other: placebo

Adalimumab

EXPERIMENTAL

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

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

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

Also known as: ABT-D2E7, Humira

Adalimumab; Placebo

placebo OTHER

Prefilled syringe, matching placebo administered subcutaneously every other week

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (9)

Site Reference ID/Investigator# 24054

Hefei, AN, 230022, China

Location

Site Reference ID/Investigator# 25522

Beijing, 100029, China

Location

Site Reference ID/Investigator# 24055

Beijing, 100032, China

Location

Site Reference ID/Investigator# 24052

Beijing, 100853, China

Location

Site Reference ID/Investigator# 24056

Guangzhou, 510630, China

Location

Site Reference ID/Investigator# 24243

Hangzhou, 310009, China

Location

Site Reference ID/Investigator# 24053

Shanghai, 200001, China

Location

Site Reference ID/Investigator# 24058

Shanghai, 200003, China

Location

Site Reference ID/Investigator# 24057

Xi'an, 710032, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Aileen Pangan

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: May 3, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2011
• Last Updated: December 1, 2011
• Results First Posted: November 4, 2011

Record last verified: 2011-11

Locations

CN (9)