Study of Adalimumab in Subjects With Axial Spondyloarthritis

• Number of Participants Achieving ASAS40 Response (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  ASAS40 response is improvement of >/=40% and absolute improvement of >/=20 units (scale of 0-100) in >/= 3 of 4 domains, plus absence of any deterioration (net worsening of > 0 units) in remaining domain: patient's global assessment of disease activity, pain (as total back pain), and physical function (Bath Ankylosing Spondylitis Function Index [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best response to 100=worst response); and inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disease Activity Index [BASDAI]).
  
  

• Number of Participants Achieving ASAS20 Response (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  ASAS20 response is improvement of >/=20% and absolute improvement of >/=10 units (scale of 0-100) in >/= 3 of 4 domains, plus no deterioration (worsening of >/=20% and >/=10 units) in remaining domain: patient's global assessment of disease activity, pain (as total back pain), and physical function (Bath Ankylosing Spondylitis Function Index [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best response to 100=worst response); and inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disease Activity Index [BASDAI]).
  
  
• Number of Participants Achieving a BASDAI50 Response (BASDAI: Bath Ankylosing Spondylitis Disease Activity Index) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (scale 0 to 10 cm) pertaining to symptoms experienced for the past week. For 5 questions (including #5 [level of morning stiffness]), the response is 0 (none) to 10 (very severe); for #6 (duration of morning stiffness), the response is 0 (0 hours) to 10 (>/= 2 hours). The overall BASDAI score has a maximum value of 10 cm. Lower scores indicate less disease activity. BASDAI50 is 50% improvement from Baseline in BASDAI score.
  
  
• Number of Participants Achieving ASAS Partial Remission (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  ASAS partial remission is an absolute score of <20 units on a 0 to 100 scale for each of 4 domains: patient's global assessment of disease activity, pain (as total back pain), and physical function (Bath AS Functional Index score [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best response to 100=worst response); and inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disability Activity Index [BASDAI]).
  
  
• Number of Participants Achieving ASAS5/6 Response (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  ASAS5/6 response is a 20% improvement in 5 of 6 domains: patient's global assessment of disease activity, pain (as total back pain), physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best to 100=worst); inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disease Activity Index [BASDAI]); spinal mobility (lateral lumbar flexion score (cm: range 0 to 10) from Bath AS Metrology Index [BASMI]); and C-reactive protein level (lower indicates less inflammation).
  
  

• Number of Participants Reporting Adverse Events [ Time Frame: Through Week 12 ] [ Designated as safety issue: Yes ]
  Adverse events were collected at designated study visits for all participants who received at least 1 dose of study drug. The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Event section for details.
  
  
• Number of Participants With Blood Hematology and Chemistry Values Common Toxicity Criteria Grade >/=3, Assessed by Central Laboratory [ Time Frame: Through Week 12 ] [ Designated as safety issue: Yes ]
  Blood was collected for analysis at designated study visits; hematology and chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher then upper normal limit or lower than lower normal limit) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.
  
  

This is a Phase 3, placebo-controlled, double-blind randomized study with an open-label phase designed to evaluate the efficacy and safety of adalimumab 40 mg administered every other week in adult patients with active axial spondyloarthritis (SpA) who are not diagnosed with ankylosing spondylitis, psoriasis, or psoriatic arthritis and who have had an inadequate response or intolerance to 1 or more nonsteroidal anti-inflammatory drugs (NSAIDs) or had a contraindication to NSAIDs. Participants receive adalimumab or placebo for 12 weeks during the double-blind phase of the study. Following the double-blind phase, all participants enter the open-label phase of the study in which they receive adalimumab for up to an additional 144 weeks. Efficacy endpoints include the Assessment of Spondyloarthritis International Society (ASAS) Working Group response criteria for patients with SpA. These response criteria were used to determine participants who were responders. ASAS response involves evaluations in the following 4 domains: participant's global assessment of disease activity, pain, function, and inflammation. The patient's global assessment of disease activity score is assessed using a 100 millimeter (mm) visual analog scale (VAS; 0 for no disease activity to 100 for severe disease activity). Pain is represented as a total back pain score and is assessed using a 100 mm VAS (0 for no pain to 100 for most severe pain). Function score is represented as the Bath Ankylosing Spondylitis (AS) Functional Index (BASFI) 100 mm VAS score (average of the ability to perform 10 activities, each scored as 0 for easy to 100 for impossible). Inflammation is determined using the morning stiffness overall level score (0 for none to 10 for very severe) and duration score (0 for 0 hours to 10 for >=2 hours) of the Bath AS Disease Activity Index (BASDAI) (mean of these items #5 and #6 scores). In addition, the BASDAI is used as an efficacy endpoint. The BASDAI is used by the participant to assess his/her disease activity. Using VAS scales, the participant answers 6 questions pertaining to symptoms experienced over the past week. For 5 questions (levels of: fatigue/tiredness; AS neck, back, or hip pain; pain/swelling; discomfort at areas tender to touch or pressure; and morning stiffness), the response scale is 0 (none) to 10 (very severe). For 1 question (duration of morning stiffness), the response scale is 0 hours to 2 or more hours. The BASDAI score has a maximum value of 10 cm. The double-blind phase of the study is complete, and results are reported for endpoints at Week 12.