Clinical Outcomes, Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab in Patients With Active Rheumatoid Arthritis (RA). A Multicenter Post-Marketing Observational Study in Routine Clinical Use

An observational study of Rheumatoid Arthritis, run by Abbott at 12 sites in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a prospective, single-arm, post marketing observational study in adult patients with active rheumatoid arthritis (RA) who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Rheumatoid Arthritis
How many people: 82 participants
Where: 12 sitesMexico
Study dates: Apr 2008to Nov 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Community sample

Who may be able to join

Patients ≥18 and <75 years of age that meet the American College of Rheumatology (ACR) criteria for RA.
Patients with active RA defined as:
≥3 tender joints and ≥3 swollen joints, or
DAS 28 score >3.1
Patients who are discontinuing treatment with either infliximab or etanercept due to:
Lack of efficacy, or

Show all 9Show fewer

Incomplete response.
Patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
Those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.

Who cannot join

The following patients will not be included in the study:
Patients who have active infections.
Patients with latent TB. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Any suggested data on the clinical history or chest x-ray.
Patients participating into another study or clinical trial
Any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Mexico12 sites

Site Reference ID/Investigator# 27882
Chihuahua City, 31000
Site Reference ID/Investigator# 27883
Chihuahua City, 31200
Site Reference ID/Investigator# 27884
Culiacán Sin., 80000
Site Reference ID/Investigator# 27888
Guadalajara, Jal., 44320
Site Reference ID/Investigator# 27886
Guadalajara, Jal., 44650
Site Reference ID/Investigator# 27887
Guadalajara, Jal., 44670
Site Reference ID/Investigator# 25943
Leon, Gto., 37000
Site Reference ID/Investigator# 28059
Mexico City, 03100
Site Reference ID/Investigator# 27885
Mexico City, 06700
Site Reference ID/Investigator# 27890
Puebla, Pue., 72000
Site Reference ID/Investigator# 27889
Puebla, Pue., 72570
Site Reference ID/Investigator# 28057
Tuxtla Gutiérrez, 29000

Other trials in Mexico

About this study

Official title: Clinical Outcomes,Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab. A Multicenter Post-Marketing Observational Study in Routine Clinical Use

The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.

Read the detailed description

This is a prospective, single-arm, post marketing observational study in adult patients with active RA who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.

The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to Adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.

Study Objectives:

Primary objective:

To assess the effectiveness of the treatment with adalimumab in patients with rheumatoid arthritis (RA) that have failed or presented an incomplete response to current treatment with either infliximab or etanercept.

Secondary objective:

To evaluate the compliance and clinical tolerability with adalimumab

Investigational Plan and Selection of Study Population:

All patients belonging to any of the centres participating in the study that meet all the inclusion criteria and none of the exclusion criteria will be considered eligible.

Patients considered eligible for the study will have to give their consent for the use and/or disclose of the patient's personal and/or health data. Patient's consent will be obtained before his/her participation in the study and will be documented in an Informed Consent Form approved by an Ethics Committee.

Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Anti-TNF, Adalimumab, Infliximab, Etanercept
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

Study groups in NCT01083160
Study group	Role	What they receive
Non responders to other anti-TNF		Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.

What is being measured

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

DAS28 (Disease Activity Score in 28 Joints)
The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to each visit is presented.
Measured: Baseline and Weeks 8,16 and 24
Tender Joint Count and Swollen Joint Count
The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.
Measured: Baseline and Weeks 8,16 and 24
Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)
Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.
Measured: Baseline and Weeks 8,16 and 24

Secondary outcomes (1)

Evaluate the Compliance and Clinical Tolerability With Adalimumab
To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section.
Measured: Baseline to Week 24

Timeline

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

Apr 2008Nov 2010

First posted9 Mar 2010 (estimated)
Study startApr 2008
Primary completionNov 2010
Study completionNov 2010

Why it stopped: The study was terminated due to low enrollment because inclusion criteria are obsolete.

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: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083160
Sponsor's protocol ID: P10-604
Acronym: FALLA
Status last verified: Jan 2012
First submitted: 19 Feb 2010
Last updated: 19 Jan 2012
Results posted: Yes, on ClinicalTrials.gov

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

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

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes,Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab. A Multicenter Post-Marketing Observational Study in Routine Clinical Use
ClinicalTrials.gov ID: NCT01083160
Acronym / sponsor ID: FALLA / P10-604
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Anti-TNF, Adalimumab, Infliximab, Etanercept
Study type: Observational
Recruitment status: TerminatedReason stopped: The study was terminated due to low enrollment because inclusion criteria are obsolete.
Enrolment: 82 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 9 Mar 2010 (estimated)
Results: Posted 2 Jan 2012

Clinical summary

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

Detailed description

The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to Adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.

Study Objectives:

Primary objective:

Secondary objective:

To evaluate the compliance and clinical tolerability with adalimumab

Investigational Plan and Selection of Study Population:

All patients belonging to any of the centres participating in the study that meet all the inclusion criteria and none of the exclusion criteria will be considered eligible.

Study design

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

Arm	Type	Receives
Non responders to other anti-TNF	–	–Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Community sample

Key inclusion criteria (9 listed)

Patients ≥18 and <75 years of age that meet the American College of Rheumatology (ACR) criteria for RA.
Patients with active RA defined as:
Patients who are discontinuing treatment with either infliximab or etanercept due to:
Patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
Those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.

Key exclusion criteria (5 listed)

Patients who have active infections.
Patients with latent TB. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Any suggested data on the clinical history or chest x-ray.
Patients participating into another study or clinical trial
Any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.

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

DAS28 (Disease Activity Score in 28 Joints)
Time frame: Baseline and Weeks 8,16 and 24
The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to each visit is presented.
Tender Joint Count and Swollen Joint Count
Time frame: Baseline and Weeks 8,16 and 24
The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.
Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)
Time frame: Baseline and Weeks 8,16 and 24
Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.

1 secondary outcome

Evaluate the Compliance and Clinical Tolerability With Adalimumab
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 2 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non Responders to Other Anti-TNF	82	81

Primary outcome: DAS28 (Disease Activity Score in 28 Joints)

Time frame: Baseline and Weeks 8,16 and 24. Mean (Standard Deviation). Unit: units on a scale

Measure	Non Responders to Other Anti-TNF n = 82
DAS 28 at Baseline (n=82)	6.04 (1.17)
DAS 28 at Week 8 (n=80)	4.63 (1.77)
DAS 28 at Week 16 (n=79)	4.05 (1.74)
DAS 28 at Week 24 (n=71)	3.68 (1.47)

Population analysed: Analysis conducted in participants with results at each time point.

Primary outcome: Tender Joint Count and Swollen Joint Count

Time frame: Baseline and Weeks 8,16 and 24. Mean (Standard Deviation). Unit: Joints

Measure	Non Responders to Other Anti-TNF n = 82
Tender joints at Baseline (n=82)	13.05 (7.29)
> Week 8 (n=80)	7.16 (6.37)
>Week 16 (n=80)	5.44 (5.76)
>Week 24 (n=71)	4.23 (5.32)
Swollen joints at Baseline (n=82)	9.56 (5.97)
>Week 8 (n=80)	4.48 (4.68)
>Week 16 (n=80)	3.15 (4.67)
>Week 24 (n=71)	2.52 (4.10)

Population analysed: Analysis conducted in participants with results at each time point.

Primary outcome: Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)

Time frame: Baseline and Weeks 8,16 and 24. Mean (Standard Deviation). Unit: Units on a scale

Measure	Non Responders to Other Anti-TNF n = 82
VAS at Baseline (n=82)	62.88 (22.31)
>Week 8 (n=80)	39.69 (25.40)
>Week 16 (n=80)	32.35 (26.02)
>Week 24 (n=71)	28.70 (23.32)

Population analysed: Analysis conducted in participants with results at each time point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of study participation was 24 weeks. Adverse events were collected from the time the participant signed the informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non Responders to Other Anti-TNF	1 of 82 (1.2%)	6 of 82 (7.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
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)
Sjogren's Syndrome, Sjögren
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
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Juan Pozos, MD study chair

Abbott

12 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, run by Abbott at 12 sites in Mexico.

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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Mexico. 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 2 Jan 2012). 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?

DAS28 (Disease Activity Score in 28 Joints) (time frame: Baseline and Weeks 8,16 and 24). 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 NCT01083160.

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 Jan 2012.