Rheumatoid ArthritisNCT01083693

Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Abbott at 20 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
How many people: 162 participants
Where: 20 sitesAustria
Study dates: Sep 2008to Jun 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care clinic and medical practice specialized in rheumatology

Who may be able to join

Patients age greater than or equal to 18
Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis).
In addition one of the following criteria must be fulfilled:
unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA
unsatisfactory NSAID response in patients with AS or
unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS.

Who cannot join

Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC
Patients participating in another study or clinical trial.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Austria20 sites

Site Reference ID/Investigator # 32372
Amstetten, A-3300
Site Reference ID/Investigator # 32368
Bludenz, A-6700
Site Reference ID/Investigator # 32367
Gloggnitz, A-2640
Site Ref # / Investigator 37123
Graz, A-8020
Site Ref # / Investigator 37125
Innsbruck, A-6020
Site Reference ID/Investigator # 32375
Klagenfurt, A-9020
Site Reference ID/Investigator # 32365
Linz, A-4020
Site Reference ID/Investigator # 32369
Linz, A-4020
Site Reference ID/Investigator # 32371
Linz, A-4020
Site Reference ID/Investigator # 32376
Linz, A-4020
Site Reference ID/Investigator # 32373
Neudorf, A-2351
Site Reference ID/Investigator # 32364
Salzburg, A-5020
Site Reference ID/Investigator # 18782
Vienna, A-1030
Site Reference ID/Investigator # 32363
Vienna, A-1030
Site Reference ID/Investigator # 32377
Vienna, A-1100
Site Reference ID/Investigator # 32378
Vienna, A-1100
Site Reference ID/Investigator # 32366
Vienna, A-1140
Site Reference ID/Investigator # 32374
Vöcklabruck, A-4840
Site Reference ID/Investigator # 32370
Weiz, A-8160
Site Ref # / Investigator 37124
Wels, A-4600

Other trials in Austria

About this study

Official title: An Open Label Multicenter Post Marketing Observational Study for the Evaluation of Quality of Life Outcomes and Tolerability of HUMIRA in Routine Clinical Use in Patients With RA PsA AS After Unsustainable Response to Disease Modifying Antirheumatic Drugs and or Biologicals

The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.

Conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Keywords: Monoclonals, Antibodies, Ankylosing Spondylitis, Antirheumatic Agents, Quality of Life, Adalimumab, rheumatoid arthritis, psoriatic arthritis
Medical subject headings: Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01083693
Study group	Role	What they receive
Rheumatoid, Psoriatic Arthritis, Ankylosing Spondylitis		Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, patients with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.

What is being measured

The primary outcome is the main question the study is designed to answer.

RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).
Measured: Baseline, months 3,6,9,12
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).
Measured: Baseline, months 3,6,9,12
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).
In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.
Measured: Baseline, months 3,6,9,12

Secondary outcomes (6)

DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).
Measured: Baseline,months 3,6,9,12
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.
Measured: Baseline, months 3,6,9,12
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).
Measured: Baseline, months 3,6,9,12
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).
Measured: Baseline, months 3,6,9,12
Erythrocyte Sedimentation Rate
Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.
Measured: Baseline, months 3,6,9,12
C-Reactive Protein
The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Measured: Baseline, months 3,6,9,12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jun 2010

First posted10 Mar 2010 (estimated)
Study startSep 2008
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083693
Sponsor's protocol ID: P10-726
Status last verified: Aug 2011
First submitted: 28 Feb 2010
Last updated: 11 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Multicenter Post Marketing Observational Study for the Evaluation of Quality of Life Outcomes and Tolerability of HUMIRA in Routine Clinical Use in Patients With RA PsA AS After Unsustainable Response to Disease Modifying Antirheumatic Drugs and or Biologicals
ClinicalTrials.gov ID: NCT01083693
Acronym / sponsor ID: P10-726
Conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Keywords: Monoclonals, Antibodies, Ankylosing Spondylitis, Antirheumatic Agents, Quality of Life, Adalimumab, rheumatoid arthritis, psoriatic arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Group Data Management Biostatistics
Study start: Sep 2008
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 26 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Rheumatoid, Psoriatic Arthritis, Ankylosing Spondylitis	–	–Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, patients with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care clinic and medical practice specialized in rheumatology

Key inclusion criteria (6 listed)

Patients age greater than or equal to 18
Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis).
unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA
unsatisfactory NSAID response in patients with AS or
unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS.

Key exclusion criteria (2 listed)

Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC
Patients participating in another study or clinical trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
Time frame: Baseline, months 3,6,9,12
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Time frame: Baseline, months 3,6,9,12
Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
Time frame: Baseline, months 3,6,9,12
European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.

6 secondary outcomes

DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
Time frame: Baseline,months 3,6,9,12
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
Time frame: Baseline, months 3,6,9,12
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Time frame: Baseline, months 3,6,9,12
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Time frame: Baseline, months 3,6,9,12
Erythrocyte Sedimentation Rate
Time frame: Baseline, months 3,6,9,12
C-Reactive Protein
Time frame: Baseline, months 3,6,9,12

Results and safety

Results posted to the registry on 26 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rheumatoid Arthritis (RA)	93	73
Psoriasis Arthritis (PsA)	28	22
Ankylosing Spondylitis (AS)	40	33

Primary outcome: RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI

Time frame: Baseline, months 3,6,9,12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Rheumatoid Arthritis (RA) n = 93	Psoriasis Arthritis (PsA) n = 28	Total n = 121
Baseline	1.2 (0.7)	0.9 (0.7)	1.1 (0.7)
3 months	0.9 (0.7)	0.4 (0.4)	0.8 (0.7)
6 months	0.8 (0.6)	0.4 (0.5)	0.7 (0.6)
9 months	0.8 (0.6)	0.3 (0.5)	0.7 (0.6)
12 months	0.7 (0.6)	0.2 (0.3)	0.6 (0.6)
Early Termination	1.4 (0.9)	0.0 (0.0)	1.2 (1.0)

Population analysed: Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.

Primary outcome: SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain

Time frame: Baseline, months 3,6,9,12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Rheumatoid Arthritis (RA) n = 93	Psoriasis Arthritis (PsA) n = 28	Ankylosing Spondylitis (AS) n = 40	Total n = 161
Physical Functioning -Baseline	51.4 (26.4)	58.1 (26.2)	53.3 (23.4)	53.1 (25.6)
Physical Functioning - 3 months	67.4 (24.3)	74.3 (21.3)	76.5 (21.9)	71.0 (23.4)
Physical Functioning - 6 months	65.3 (24.4)	76.0 (21.9)	79.4 (22.2)	70.9 (24.1)
Physical Functioning - 9 months	67.4 (24.6)	79.8 (19.5)	81.4 (18.7)	73.4 (23.1)
Physical Functioning -12 months	70.3 (23.8)	85.9 (13.2)	80.4 (24.5)	75.9 (23.1)
Physical Functioning - Early Termination	33.3 (28.6)	NA (NA)	NA (NA)	33.3 (28.6)
Role Functioning -Physical - Baseline	29.8 (40.5)	38.9 (43.5)	25.0 (32.2)	30.3 (39.2)
Role Functioning - Physical - 3 months	57.3 (43.5)	58.7 (41.0)	67.4 (38.8)	60.2 (41.8)

Population analysed: Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[participants who discontinued the study early\]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.

Primary outcome: EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression

Time frame: Baseline, months 3,6,9,12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Rheumatoid Arthritis (RA) n = 93	Psoriasis Arthritis (PsA) n = 28	Ankylosing Spondylitis (AS) n = 40	Total n = 161
EQ-5D - Baseline	0.5 (0.3)	0.5 (0.3)	0.4 (0.3)	0.5 (0.3)
EQ-5D - 3 months	0.7 (0.2)	0.8 (0.2)	0.8 (0.2)	0.7 (0.2)
EQ-5D - 6 months	0.7 (0.2)	0.8 (0.1)	0.8 (0.3)	0.8 (0.2)
EQ-5D - 9 months	0.7 (0.2)	0.8 (0.2)	0.8 (0.2)	0.8 (0.2)
EQ-5D - 12 months	0.8 (0.2)	0.8 (0.1)	0.8 (0.3)	0.8 (0.2)
EQ-5D - Early Termination	0.3 (0.5)	1.0 (NA)	NA (NA)	0.4 (0.5)
Thermometer Scale - Baseline	49.0 (21.5)	52.5 (24.8)	40.2 (22.6)	47.4 (22.7)
Thermometer Scale - 3 months	64.8 (22.0)	68.7 (21.0)	64.9 (25.6)	65.5 (22.7)

Population analysed: Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rheumatoid Arthritis (RA)	6 of 93 (6.5%)	10 of 93 (10.8%)	Not reported
Psoriasis Arthritis (PsA)	2 of 28 (7.1%)	1 of 28 (3.6%)	Not reported
Ankylosing Spondylitis (AS)	0 of 40 (0%)	1 of 40 (2.5%)	Not reported
Total	8 of 161 (5%)	12 of 161 (7.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Astrid Dworan-Timler, MD study director

Abbott AUSTRIA

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Abbott at 20 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI (time frame: Baseline, months 3,6,9,12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01083693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.