A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct )

An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott).

Completed

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

Trial summary

This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab). Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
How many people: 5,940 participants
Where: No sites listed yet
Study dates: 13 May 2004to 11 Jan 2018
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Rheumatologists

Who may be able to join

Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines.
Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Who cannot join

Contraindications according to the summary of product characteristics.
Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).

About this study

Official title: A Five Year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis or Psoriatic Arthritis Who Are Treated With HUMIRA (Adalimumab)

This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).

Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Keywords: Multicenter study
Medical subject headings: Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing

What participants receive

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

Study groups in NCT01078558
Study group	Role	What they receive
Patients with rheumatic disease		Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

What is being measured

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

Change From Baseline in Physician's Assessment of Disease Activity Over Time
Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity.
Measured: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Tender Joints Over Time
A total of 28 joints were assessed for tenderness.
Measured: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Swollen Joints Over Time
A total of 28 joints were assessed for swelling.
Measured: Baseline, Months 3, 6, 12, 24, 60
Inflammatory Parameter: Change From Baseline in CRP Over Time
Measured: Baseline, Months 3, 6, 12, 24, 60
Inflammatory Parameter: Change From Baseline in ESR Over Time
Measured: Baseline, Months 3, 6, 12, 24, 60
Physical Function: Change From Baseline in HAQ% Over Time
The HAQ score measures quality of life in terms of physical function and 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 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement.
Measured: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in DAS28 Over Time: RA Participants
The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Months 3, 6, 12, 24, 60
DAS28 Category Over Time: RA Participants
The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Months 3, 6, 12, 24, 60
BSA With PsA Over Time: PsA Participants
Measured: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.
Measured: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.
Measured: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in BASDAI Over Time: AS Participants
BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms.
Measured: Baseline, Months 3, 6, 12, 24, 60
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Measured: up to 60 months

Timeline

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

13 May 200411 Jan 2018

First posted2 Mar 2010 (estimated)
Study start13 May 2004
Primary completion11 Jan 2018
Study completion11 Jan 2018

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: Case only
Time perspective: Prospective
Enrolment: 5,940 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078558
Sponsor's protocol ID: HUM04-28
Acronym: ProAct
Status last verified: Nov 2018
First submitted: 1 Mar 2010
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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?

Official record

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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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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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Five Year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis or Psoriatic Arthritis Who Are Treated With HUMIRA (Adalimumab)
ClinicalTrials.gov ID: NCT01078558
Acronym / sponsor ID: ProAct / HUM04-28
Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Keywords: Multicenter study
Study type: Observational
Recruitment status: Completed
Enrolment: 5,940 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Veeda Clinical Research
Study start: 13 May 2004 (actual)
Primary completion: 11 Jan 2018 (actual)
Study completion: 11 Jan 2018 (actual)
First posted: 2 Mar 2010 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

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

This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with rheumatic disease	–	–Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Rheumatologists

Key inclusion criteria (2 listed)

Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines.
Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Key exclusion criteria (2 listed)

Contraindications according to the summary of product characteristics.
Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).

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

Change From Baseline in Physician's Assessment of Disease Activity Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity.
Change From Baseline in Tender Joints Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
A total of 28 joints were assessed for tenderness.
Change From Baseline in Swollen Joints Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
A total of 28 joints were assessed for swelling.
Inflammatory Parameter: Change From Baseline in CRP Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
Inflammatory Parameter: Change From Baseline in ESR Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
Physical Function: Change From Baseline in HAQ% Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
The HAQ score measures quality of life in terms of physical function and 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 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement.
Change From Baseline in DAS28 Over Time: RA Participants
Time frame: Baseline, Months 3, 6, 12, 24, 60
The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
DAS28 Category Over Time: RA Participants
Time frame: Baseline, Months 3, 6, 12, 24, 60
The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
BSA With PsA Over Time: PsA Participants
Time frame: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Time frame: Baseline, Months 3, 6, 12, 24, 60
Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Time frame: Baseline, Months 3, 6, 12, 24, 60
Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.
Change From Baseline in BASDAI Over Time: AS Participants
Time frame: Baseline, Months 3, 6, 12, 24, 60
BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms.
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation
Time frame: up to 60 months
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With RA	2,836	818
Participants With PsA	1,127	372
Participants With AS	1,957	596

Primary outcome: Change From Baseline in Physician's Assessment of Disease Activity Over Time

Time frame: Baseline, Months 3, 6, 12, 24, 60. Mean (Standard Deviation). Unit: units on a scale

Measure	Participants With RA n = 1781	Participants With PsA n = 687	Participants With AS n = 1232
Month 3	-34.4 (24.7)	-36.2 (24.8)	-40.2 (28.4)
Month 6	-38.6 (26.4)	-40.2 (25.6)	-44.5 (28.7)
Month 12	-40.4 (27.2)	-43.2 (26.6)	-46.6 (28.7)
Month 24	-42.4 (26.9)	-42.2 (27.2)	-46.6 (28.7)
Month 60	-44.2 (27.3)	-44.8 (29.3)	-50.2 (29.9)

Population analysed: All participants with a Baseline and post-baseline assessment at given time point.

Primary outcome: Change From Baseline in Tender Joints Over Time

Time frame: Baseline, Months 3, 6, 12, 24, 60. Mean (Standard Deviation). Unit: tender joints

Measure	Participants With RA n = 1959	Participants With PsA n = 755	Participants With AS n = 634
Month 3	-8.5 (8.0)	-6.8 (7.8)	-1.6 (3.5)
Month 6	-9.4 (8.6)	-7.6 (7.6)	-1.9 (4.6)
Month 12	-10.2 (8.9)	-8.0 (7.7)	-1.9 (4.1)
Month 24	-10.4 (8.9)	-7.9 (7.9)	-2.0 (3.9)
Month 60	-11.2 (8.2)	-8.3 (8.7)	-1.9 (3.2)

Population analysed: All participants with a Baseline and post-baseline assessment at given time point.

Primary outcome: Change From Baseline in Swollen Joints Over Time

Time frame: Baseline, Months 3, 6, 12, 24, 60. Mean (Standard Deviation). Unit: swollen joints

Measure	Participants With RA n = 1982	Participants With PsA n = 755	Participants With AS n = 623
Month 3	-7.3 (6.7)	-5.6 (5.7)	-1.3 (3.1)
Month 6	-8.2 (7.1)	-6.1 (5.2)	-1.4 (3.4)
Month 12	-8.5 (7.3)	-6.5 (5.4)	-1.3 (2.9)
Month 24	-9.0 (7.4)	-6.5 (5.8)	-1.4 (2.8)
Month 60	-9.4 (6.7)	-6.8 (6.4)	-1.4 (2.4)

Population analysed: All participants with a Baseline and post-baseline assessment at given time point.

Primary outcome: Inflammatory Parameter: Change From Baseline in CRP Over Time

Time frame: Baseline, Months 3, 6, 12, 24, 60. Mean (Standard Deviation). Unit: mg/dL

Measure	Participants With RA n = 1607	Participants With PsA n = 568	Participants With AS n = 838
Month 3	-2.1 (8.0)	-1.6 (7.1)	-2.8 (25.1)
Month 6	-1.9 (6.7)	-1.8 (9.0)	-2.6 (26.1)
Month 12	-1.9 (7.3)	-1.6 (5.5)	-2.7 (27.5)
Month 24	-1.9 (7.0)	-1.2 (9.0)	-1.3 (9.3)
Month 60	-1.6 (13.2)	0.0 (13.8)	-0.7 (4.6)

Population analysed: All participants with a Baseline and post-baseline assessment at given time point.

Adverse events

Time frame: up to Month 60. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	934 of 5,920 (15.8%)	0 of 5,920 (0%)	54 of 5,920

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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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.

AbbVie Inc. study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott).

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 2 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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 5 Jul 2019). 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?

Change From Baseline in Physician's Assessment of Disease Activity Over Time (time frame: Baseline, Months 3, 6, 12, 24, 60). The study lists 13 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 NCT01078558.

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 5 Jul 2019.