DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: adalimumab (D2E7) (Biological); placebo (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Summary

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

Clinical Details

Official title: A Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

Secondary outcome:

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

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

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

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

Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260

BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure

Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260

Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure

Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260

Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure

Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure

Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure

Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure

Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260

Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260

Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure

Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260

Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260

Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260

Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260

Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260

Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260

Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260

Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260

Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure

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

Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260

Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260

Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure

Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure

Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure

Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure

Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure

Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure

Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure

Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure

Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure

Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure

Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure

Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure

Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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

Locations and Contacts

Site Ref # / Investigator 74, Calgary, Alberta T2N 4N1, Canada

Site Ref # / Investigator 70, Edmonton, Alberta T6G 2S2, Canada

Site Ref # / Investigator 79, Vancouver, British Columbia V5Z 1L7, Canada

Site Ref # / Investigator 64, Winnipeg, Manitoba R3N OK6, Canada

Site Ref # / Investigator 78, St. John's, Newfoundland and Labrador A1C 5B8, Canada

Site Ref # / Investigator 62, Toronto, Ontario M5T 2S8, Canada

Site Ref # / Investigator 63, Toronto, Ontario M5L 3L9, Canada

Site Ref # / Investigator 75, Toronto, Ontario M4N 3M5, Canada

Site Ref # / Investigator 77, Saskatoon, Saskatchewan S7K 0H6, Canada

Additional Information

Starting date: December 2003
Last updated: June 24, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017