Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

NCT00195819 | Completed Phase 3 Results

• 1 other identifier: M03-606
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; adalimumab

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12

  ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) 0 \[no disease activity\]-100 \[high disease activity\]) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0\[none\]-100 \[severe\]), Total Back Pain VAS; (0 \[no pain\]-100 \[severe\]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 \[easy \]-100\[impossible\]); and Inflammation VAS; (1 \[no pain\] to 10 \[severe pain\]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.

  Week 12

• Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score

  Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 \[no change\] to 72 \[progression\]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.

  Baseline and Week 104

Secondary Outcomes (42)

• Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure

  Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

• Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure

  Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

• Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure

  Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

• Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260

  Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

• Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure

  Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260

Study Arms (2)

Adalimumab

EXPERIMENTAL

Biological: adalimumab (D2E7)

Placebo

PLACEBO COMPARATOR

Biological: placebo

Interventions

adalimumab (D2E7) BIOLOGICAL

Adalimumab 40 mg every other week (eow)

Also known as: ABT-D2E7, adalimumab, Humira

Adalimumab

placebo BIOLOGICAL

Placebo every other week (eow)

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history.
• Subject met the definition of AS based on the Modified New York Criteria.
• Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator

You may not qualify if:

• Subject had previously received anti-TNF therapy.
• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast-feeding or considering becoming pregnant

Sponsors & Collaborators

• Abbott: lead

Study Sites (9)

Site Ref # / Investigator 74

Calgary, Alberta, T2N 4N1, Canada

Location

Site Ref # / Investigator 70

Edmonton, Alberta, T6G 2S2, Canada

Location

Site Ref # / Investigator 79

Vancouver, British Columbia, V5Z 1L7, Canada

Location

Site Ref # / Investigator 64

Winnipeg, Manitoba, R3N OK6, Canada

Location

Site Ref # / Investigator 78

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Site Ref # / Investigator 75

Toronto, Ontario, M4N 3M5, Canada

Location

Site Ref # / Investigator 63

Toronto, Ontario, M5L 3L9, Canada

Location

Site Ref # / Investigator 62

Toronto, Ontario, M5T 2S8, Canada

Location

Site Ref # / Investigator 77

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Related Publications (3)

• Revicki DA, Rentz AM, Luo MP, Wong RL. Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis. Health Qual Life Outcomes. 2011 May 22;9:36. doi: 10.1186/1477-7525-9-36.

  PMID: 21600054 DERIVED

• van der Heijde D, Salonen D, Weissman BN, Landewe R, Maksymowych WP, Kupper H, Ballal S, Gibson E, Wong R; Canadian (M03-606) study group; ATLAS study group. Assessment of radiographic progression in the spines of patients with ankylosing spondylitis treated with adalimumab for up to 2 years. Arthritis Res Ther. 2009;11(4):R127. doi: 10.1186/ar2794. Epub 2009 Aug 24.

  PMID: 19703304 DERIVED

• Lambert RG, Salonen D, Rahman P, Inman RD, Wong RL, Einstein SG, Thomson GT, Beaulieu A, Choquette D, Maksymowych WP. Adalimumab significantly reduces both spinal and sacroiliac joint inflammation in patients with ankylosing spondylitis: a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2007 Dec;56(12):4005-14. doi: 10.1002/art.23044.

  PMID: 18050198 DERIVED

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

Limitations and Caveats

The modified SASSS was pooled with a study (NCT00085644) similar in structure and sharing the same endpoints as this study.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: June 1, 2009
• Last Updated: June 28, 2011
• Results First Posted: April 28, 2010

Record last verified: 2011-06

Locations

CA (9)