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

Abbott

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Other: placebo; Biological: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01114880

M11-991

Details and patient eligibility

About

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)

Full 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).

Enrollment: 344 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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344 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

Biological: adalimumab

Adalimumab

Experimental group

Description:

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

Treatment:

Biological: adalimumab