Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in Belgium.

Completed

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

Trial summary

People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: SC anti-TNF
How many people: 62 participants
Where: 1 siteBelgium
Study dates: Nov 2010to Feb 2014
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: patients seen in a rheumatology practice

Who may be able to join

Patients who:
Are active RA patients (as judged by treating MD)
Are 18 years of age or older at time of consent
Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX

Who cannot join

Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
Participation in other clinical or observational trials

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UZ Gasthuisberg
Leuven, 3000

Other trials in Belgium

About this study

Official title: Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy

People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.

Read the detailed description

Observational prospective study Purely descriptive

Conditions: Rheumatoid Arthritis
Being tested: SC anti-TNF
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

SC anti-TNFOther
SC anti-TNF

Study groups in NCT01521884
Study group	Role	What they receive
RA Patients treated with SC anti-TNF		Not described Receives: Other: SC anti-TNF

What is being measured

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

Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Measured: Baseline
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Measured: Month 6
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Measured: Month 12
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Measured: Month 18
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Measured: Month 24

Secondary outcomes (4)

Visual Analog Scale (VAS) Fatigue Score
Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
Measured: Baseline, Month 6, 12, 18, 24
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score=more disease activity (DA). DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA
Measured: Baseline, Month 6, 12, 18, 24
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.
Measured: Baseline, Month 6, 12, 18, 24
Health Assessment Questionnaire (HAQ) Total Score
HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of item scores. HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.
Measured: Baseline, Month 6, 12, 18, 24

Timeline

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

Nov 2010Feb 2014

First posted31 Jan 2012 (estimated)
Study startNov 2010
Primary completionFeb 2014
Study completionFeb 2014

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.
More trials run by PfizerThe sponsor's other registered studies.
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
Time perspective: Prospective
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01521884
Sponsor's protocol ID: 0881A1-4748
Other IDs: B1801046
Status last verified: Feb 2015
First submitted: 19 Aug 2011
Last updated: 19 Feb 2015
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 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
ClinicalTrials.gov ID: NCT01521884
Acronym / sponsor ID: 0881A1-4748
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 31 Jan 2012 (estimated)
Results: Posted 19 Feb 2015

Clinical summary

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

People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.

Detailed description

Observational prospective study Purely descriptive

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
RA Patients treated with SC anti-TNF	–	Other: SC anti-TNF

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients seen in a rheumatology practice

Key inclusion criteria (4 listed)

Are active RA patients (as judged by treating MD)
Are 18 years of age or older at time of consent
Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX

Key exclusion criteria (2 listed)

Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
Participation in other clinical or observational trials

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

Interventions

Intervention	Type	Arms
SC anti-TNFSC anti-TNF	Other	RA Patients treated with SC anti-TNF

Primary outcome

Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
Time frame: Baseline
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
Time frame: Month 6
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
Time frame: Month 12
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
Time frame: Month 18
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
Time frame: Month 24
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.

4 secondary outcomes

Visual Analog Scale (VAS) Fatigue Score
Time frame: Baseline, Month 6, 12, 18, 24
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
Time frame: Baseline, Month 6, 12, 18, 24
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Time frame: Baseline, Month 6, 12, 18, 24
Health Assessment Questionnaire (HAQ) Total Score
Time frame: Baseline, Month 6, 12, 18, 24

Results and safety

Results posted to the registry on 19 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)	62	35

Primary outcome: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n = 62
AIMS2-Physical Score (n=59)	3.5 (1.7)
AIMS2-Affect Score (n=59)	4.8 (1.7)
AIMS2-Symptom Score (n=58)	7.3 (1.8)

Population analysed: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here "n" = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

Primary outcome: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6

Time frame: Month 6. Mean (Standard Deviation). Unit: units on a scale

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n = 62
AIMS2-Physical Score (n=47)	2.3 (1.7)
AIMS2-Affect Score (n=49)	3.8 (1.9)
AIMS2-Symptom Score (n=49)	5.1 (2.5)

Primary outcome: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12

Time frame: Month 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n = 42
AIMS2-Physical Score	2.1 (1.3)
AIMS2-Affect Score	3.5 (1.8)
AIMS2-Symptom Score	4.3 (2.7)

Population analysed: ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here "N" (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.

Primary outcome: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18

Time frame: Month 18. Mean (Standard Deviation). Unit: units on a scale

Measure	Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) n = 62
AIMS2-Physical Score (n=30)	2.6 (1.7)
AIMS2-Affect Score (n=31)	3.4 (1.8)
AIMS2-Symptom Score (n=31)	4.5 (2.1)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)	1 of 62 (1.6%)	4 of 62 (6.5%)	Not reported

Limitations and caveats (from the sponsor): Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link 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.

Pfizer CT.gov Call Center study director

Pfizer

1 site 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, run by Pfizer at 1 site in Belgium.

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 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 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 19 Feb 2015). 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?

Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline (time frame: Baseline). The study lists 5 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 NCT01521884.

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 19 Feb 2015.