Rheumatoid ArthritisNCT01273519

Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by AbbVie (prior sponsor, Abbott) at 15 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 olderHealthy volunteers can take part
Conditions the study is for: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
How many people: 155 participants
Where: 15 sitesAustria
Study dates: Jan 2011to Jan 2013
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
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:
unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis

Who cannot join

Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
Patients participating in another study program or clinical trial
Patients who have been treated with Humira before

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Austria15 sites

Site Reference ID/Investigator# 52144
Bludenz, 6700
Site Reference ID/Investigator# 44915
Fürstenfeld, 8280
Site Reference ID/Investigator# 44910
Gloggnitz, A-2640
Site Reference ID/Investigator# 44914
Graz, A-8020
Site Reference ID/Investigator# 52143
Innsbruck, 6020
Site Reference ID/Investigator# 44916
Klagenfurt, A-9020
Site Reference ID/Investigator# 44911
Linz, 4030
Site Reference ID/Investigator# 44912
Linz, A-4020
Site Reference ID/Investigator# 44913
Linz, A-4020
Site Reference ID/Investigator# 44906
Neudorf, A-2351
Site Reference ID/Investigator# 44909
Sankt Pölten, 3100
Site Reference ID/Investigator# 52145
Spitz, 3620
Site Reference ID/Investigator# 44908
Stockerau, 2000
Site Reference ID/Investigator# 67062
Vienna, 1040
Site Reference ID/Investigator# 57304
Vöcklabruck, A-4840

Other trials in Austria

About this study

The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.

Read the detailed description

This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a Humira-containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.

Conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Keywords: Ankylosing, Rheumatoid, Antibodies, Arthritis, Pain, Antirheumatic Agents, Psoriatic, Spondylitis, Monoclonals
Medical subject headings: Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Arthritis, Pain, Spondylitis

What participants receive

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

Study groups in NCT01273519
Study group	Role	What they receive
RA, PsA, AS		Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

What is being measured

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

Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Measured: Baseline, Months 3, 6, 9, 12
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Measured: Baseline, Months 3, 6, 9, 12
Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
Participants measured their present pain intensity by specifying their level of pain in response to the question "How intensive is your pain at present?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Measured: Baseline, Month 12
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Measured: Baseline, Months 3, 6, 9, 12
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question "How intensive was your pain on average in the past 3 months?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Measured: Baseline, Month 12
Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).
Measured: Baseline, Month 12
Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.
Measured: Baseline, Month 12
Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.
Measured: Baseline, Month 12
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.
Measured: Baseline, Month 12

Secondary outcomes (7)

Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 [worst] to 100 [best ]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.
Measured: Baseline, Months 3, 6, 9, 12
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI < 0.5.
Measured: Baseline, Months 3, 6, 9, 12
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
Measured: Baseline, Months 3, 6, 9, 12
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used to answer the questions on the test.
Measured: Baseline, Months 3, 6, 9, 12
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).
Measured: Baseline, Months 3, 6, 9, 12
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.
Measured: Baseline, Months 3, 6, 9, 12
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.
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.

Jan 2011Jan 2013

First posted10 Jan 2011 (estimated)
Study startJan 2011
Primary completionJan 2013
Study completionJan 2013

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: 155 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01273519
Sponsor's protocol ID: P12-585
Status last verified: Feb 2014
First submitted: 7 Jan 2011
Last updated: 26 Mar 2014
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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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab
ClinicalTrials.gov ID: NCT01273519
Acronym / sponsor ID: P12-585
Conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Keywords: Ankylosing, Rheumatoid, Antibodies, Arthritis, Pain, Antirheumatic Agents, Psoriatic, Spondylitis
Study type: Observational
Recruitment status: Completed
Enrolment: 155 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Raffeiner GmbH
Study start: Jan 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 10 Jan 2011 (estimated)
Results: Posted 24 Feb 2014

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
RA, PsA, AS	–	–Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: primary care clinic and medical practice specialized in rheumatology

Key inclusion criteria (4 listed)

Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:

Key exclusion criteria (3 listed)

Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
Patients participating in another study program or clinical trial
Patients who have been treated with Humira before

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

Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
Time frame: Baseline, Month 12
Participants measured their present pain intensity by specifying their level of pain in response to the question "How intensive is your pain at present?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
Time frame: Baseline, Month 12
Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question "How intensive was your pain on average in the past 3 months?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
Time frame: Baseline, Month 12
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).
Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12
Time frame: Baseline, Month 12
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.
Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
Time frame: Baseline, Month 12
Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
Time frame: Baseline, Month 12
Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.

7 secondary outcomes

Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12

Results and safety

Results posted to the registry on 24 Feb 2014, 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 Arthiritis (RA)	78	59
Psoriatic Arthritis (PsA)	30	25
Ankylosing Spondylitis (AS)	47	39

Primary outcome: Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12

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

Measure	RA, PsA, AS n = 152
Baseline, n=152	58.32 (22.01)
Month 3, n=143	34.28 (24.74)
Month 6, n=116	27.14 (22.69)
Month 9, n=112	21.71 (20.21)
Month 12, n=105	14.62 (16.88)

Population analysed: All participants with an assessment. n=number of participants with an assessment at time point.

Primary outcome: Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12

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

Measure	RA, PsA, AS n = 152
Baseline, n=152	56.55 (21.57)
Month 3, n=141	31.19 (23.95)
Month 6, n=114	25.32 (22.13)
Month 9, n=108	19.06 (18.46)
Month 12, n=105	12.2 (15.1)

Population analysed: All participants with an assessment. n=number of participants with an assessment at time point.

Primary outcome: Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12

Time frame: Baseline, Month 12. Number. Unit: participants

Measure	RA, PsA, AS: Baseline n = 150	RA, PsA, AS: Month 12 n = 105
No Pain	4	49
Mild Pain	22	40
Moderate Pain	61	14
Severe Pain	63	2

Population analysed: All participants with an assessment at time point.

Primary outcome: Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12

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

Measure	RA, PsA, AS n = 150
Baseline, n=150	64.31 (19.79)
Month 3, n=142	38.24 (25.12)
Month 6, n=114	30.89 (21.5)
Month 9, n=109	24.74 (20.3)
Month 12, n=105	17.36 (17.57)

Population analysed: All participants with an assessment. n=number of participants with an assessment at time point.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RA, PsA, AS	3 of 155 (1.9%)	21 of 155 (13.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

AbbVie Austria

15 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 AbbVie (prior sponsor, Abbott) at 15 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 4 inclusion and 3 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 24 Feb 2014). 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?

Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 (time frame: Baseline, Months 3, 6, 9, 12). The study lists 9 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 NCT01273519.

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 26 Mar 2014.