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Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis (ATLAS)

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

adalimumab (D2E7)

placebo

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must be >= 18 years of age meet Modified NY Criteria definition of ankylosing spondylitis (AS) have diagnosis of active AS based on protocol specified criteria inadequate response or intolerance to >= 1 nonsteroidal antiinflammatory drug (NSAID) be able and willing to learn to self-administer subcutaneous (SC) injections Exclusion Criteria: Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease Previous anti-tumor necrosis factor therapy Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine) Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing Biologic or investigational therapy within 6 weeks of study dosing Treatment with intravenous (IV) antibiotics within 30 days of study dosing Treatment with oral antibiotics within 14 days of study dosing

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adalimumab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).

ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 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]), BASFI VAS (0 [easy]-100[impossible]); and Inflammation VAS (0 [none]-10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.

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.

Secondary Outcome Measures

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

ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 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]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS (0 [none] to 10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.

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

ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.

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

ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]), Total Back Pain VAS; (0 [no pain] - 100 [severe]), BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as defined as a worsening of >= 20% and a net worsening of >= 10 units. Applied to each scale and not to an overall global scale.

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

Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.

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

The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.

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

BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 100-mm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 100 (impossible).

Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure

BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.

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

Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).

Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure

Participants assessed disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain). A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.

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

Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure

The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement. A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe].

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

The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

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

The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

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

The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

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

The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

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

Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation. A decrease in CRP indicates improvement.

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

ASAS 40 responders - improvement of >=40% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of any deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.

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

The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage. ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP]).

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

ASAS partial remission was calculated as follows: A value below 20 on a 0 - 100 point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function, and Inflammation). Partial remission is also regarded as a low disease activity state.

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

BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.

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

The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE. An increase in chest expansion represents improvement

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

MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 to 13 (minimum to maximum number and severity of enthesitis).

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

BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported.

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

Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present ("1"), absent ("0") or injected/replaced ("9"). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5).

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

Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present ("1"), absent ("0") or injected/replaced ("9"). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Hip, Knee, Ankle, and Metatarsophalangeal (1-5).

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

The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.

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

The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.

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

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.

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

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.

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

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a >= 3.0 point increase during exposure to adalimumab.

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

The HUI-3 is a generic approach to the measurement of health status and assessment of health-related quality of life (HRQL). The HUI-3 classification is comprised of a total score and 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. The attributes are measures on a scale from the worst score of 0 to best score of 1. The total score scale ranges from dead (= 0) and perfect health (= 1). The total score can have a negative score that is interpreted as worse than dead and the lower limit is -0.36. An increase in the HUI-3 score represents improvement.

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

ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Each statement on the ASQoL is given a score of "1" or "0." All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement.

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

ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are participants with a minimal clinically important difference (MCID) <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab.

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

Completed by subject at each visit. The Patient Acceptable Symptoms State (PASS) was a participant-reported outcome where participants were expected to respond (yes/no) to the following question: Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?

Full Information

NCT ID

NCT00085644

First Posted

June 10, 2004

Last Updated

April 18, 2011

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00085644

Brief Title

Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Acronym

ATLAS

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 Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

315 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

adalimumab (D2E7)

Other Intervention Name(s)

ABT-D2E7, adalimumab, Humira

Intervention Description

Adalimumab 40 mg every other week, subcutaneous

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

Placebo every other week, subcutaneous

Primary Outcome Measure Information:

Title

Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).

Description

Time Frame

Week 12

Title

Description

Time Frame

Week 104

Secondary Outcome Measure Information:

Title

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

Description

ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 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]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS (0 [none] to 10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

Time Frame

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

Title

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

Description

The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring: Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

Time Frame

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

Title

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

Description

The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning). Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a >= 3.0 point increase during exposure to adalimumab.

Time Frame

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

Title

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

Description

Time Frame

Baseline, Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Redden, MD, PhD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35924

Country

United States

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

City

Boise

State/Province

Idaho

ZIP/Postal Code

83706

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

City

Baltimore,

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25541333

Citation

van der Heijde D, Breban M, Halter D, DiVittorio G, Bratt J, Cantini F, Kary S, Pangan AL, Kupper H, Rathmann SS, Sieper J, Mease PJ. Maintenance of improvement in spinal mobility, physical function and quality of life in patients with ankylosing spondylitis after 5 years in a clinical trial of adalimumab. Rheumatology (Oxford). 2015 Jul;54(7):1210-9. doi: 10.1093/rheumatology/keu438. Epub 2014 Dec 25.

Results Reference

derived

PubMed Identifier

21813060

Citation

Kimel M, Revicki D, Rao S, Fryback D, Feeny D, Harnam N, Thompson C, Cifaldi M. Norms-based assessment of patient-reported outcomes associated with adalimumab monotherapy in patients with ankylosing spondylitis. Clin Exp Rheumatol. 2011 Jul-Aug;29(4):624-32. Epub 2011 Aug 31.

Results Reference

derived

PubMed Identifier

21600054

Citation

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.

Results Reference

derived

PubMed Identifier

20100797

Citation

Reilly MC, Gooch KL, Wong RL, Kupper H, van der Heijde D. Validity, reliability and responsiveness of the Work Productivity and Activity Impairment Questionnaire in ankylosing spondylitis. Rheumatology (Oxford). 2010 Apr;49(4):812-9. doi: 10.1093/rheumatology/kep457. Epub 2010 Jan 25.

Results Reference

derived

PubMed Identifier

19703304

Citation

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.

Results Reference

derived

PubMed Identifier

19686597

Citation

van der Heijde DM, Revicki DA, Gooch KL, Wong RL, Kupper H, Harnam N, Thompson C, Sieper J; ATLAS Study Group. Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis. Arthritis Res Ther. 2009;11(4):R124. doi: 10.1186/ar2790. Epub 2009 Aug 17.

Results Reference

derived

PubMed Identifier

18701556

Citation

van der Heijde D, Schiff MH, Sieper J, Kivitz AJ, Wong RL, Kupper H, Dijkmans BA, Mease PJ, Davis JC Jr; ATLAS Study Group. Adalimumab effectiveness for the treatment of ankylosing spondylitis is maintained for up to 2 years: long-term results from the ATLAS trial. Ann Rheum Dis. 2009 Jun;68(6):922-9. doi: 10.1136/ard.2007.087270. Epub 2008 Aug 13.

Results Reference

derived

PubMed Identifier

18383418

Citation

Dougados M, Luo MP, Maksymowych WP, Chmiel JJ, Chen N, Wong RL, Davis JC Jr, van der Heijde D; ATLAS STUDY GROUP. Evaluation of the patient acceptable symptom state as an outcome measure in patients with ankylosing spondylitis: data from a randomized controlled trial. Arthritis Rheum. 2008 Apr 15;59(4):553-60. doi: 10.1002/art.23527.

Results Reference

derived

PubMed Identifier

18056755

Citation

van der Heijde D, Pangan AL, Schiff MH, Braun J, Borofsky M, Torre J, Davis JC Jr, Wong RL, Kupper H, Collantes E; ATLAS Study Group. Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis. Ann Rheum Dis. 2008 Sep;67(9):1218-21. doi: 10.1136/ard.2007.082529. Epub 2007 Dec 4.

Results Reference

derived

Learn more about this trial

Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

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