Rheumatoid Arthritis (RA)NCT01585064

Optimization of Treatment With Adalimumab (Humira)

An observational study of Rheumatoid Arthritis (RA), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

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

The purpose of this trial is to assess the effect of two Intensive Outpatient Management Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid Arthritis (RA) that are treated with adalimumab. This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis (RA)
What is being tested?: DAS28-IOMS, 0SJ-IOMS and Routine Care (RC)
How many people: 309 participants
Where: 1 siteCanada
Study dates: Aug 2006to Feb 2010
Phase: Observational
Are there results?: None posted in the registry

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 will be recruited from approximately 40 sites across Canada. The study sample selection will be stratified in order to ensure adequate representation from all Canadian regions.

Who may be able to join

Patient has a diagnosis of rheumatoid arthritis
Patient is > 18 years of age
Patient is naïve to HUMIRA® (adalimumab) therapy.
Patient has access to reimbursement for their standard of care.
If female, patient is either: 1) not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or 2) of childbearing potential and practicing one of the following methods of birth control:
condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)

Show all 11Show fewer

contraceptives (oral or parenteral) for three months prior to enrollment in the study
a vasectomized partner
total abstinence from sexual intercourse
If female and of childbearing potential, patient must have a negative serum pregnancy test performed at Screening.
Patient is able to give written informed consent and to complete the survey requirements.

Who cannot join

Patients had a history of cancer within the past 5 years other than a successfully treated basal cell carcinoma and/or localized carcinoma in situ of the cervix
Patients with a history either of lymphoma or leukemia.
Patients with a history of untreated active tuberculosis, or listeriosis, or other currently active infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic protozoal or fungal infections.
Patients with a known positive HIV test.
Patients with a known positive HepBsAg test.
Patients with a persistent or severe infection(s) requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days, prior to enrollment.

Show all 9Show fewer

Female patients who are breast-feeding.
Patients with clinically significant concurrent illness that in the investigator's judgment may influence the study outcomes (such as MS, moderate to severe CHF, etc,).
Patients with any condition that would prevent participation or completion in this study including language limitation or possibility that the patient will not be available for the complete study period (18 months).

Trial locations and contacts

1 site in 1 country.

Canada1 site

Lawson Health Research Institute
London, Ontario, N6A 4V2

Other trials in Canada

About this study

Official title: Optimization of Treatment With Adalimumab (HUMIRA): A Multi-center, Randomized, Single Blind, Controlled Clinical Trial

This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial. A total of 300 patients (100 per group) with RA will be recruited from approximately 40 sites across Canada.

Read the detailed description

Background:

Rheumatoid arthritis (RA) is chronic systemic inflammatory disease often leading to damage and disability (Lee DM, et al.). RA is associated with a shorter life expectancy (Pincus T, et al.) and, if untreated, can lead to significantly lower quality of life and functional impairment (Bradley EM, et al.).

The concept of tight control, involving the treatment of patients to specified targets with close monitoring and treatment adjustment when necessary, has been trialed in early RA. Many targeted studies have demonstrated improved outcomes or faster target achievement in early RA.

The TICORA trial, which studied a group of patients who had active disease but who had not progressed to multiple DMARDs or biologic therapy, demonstrated that the usage of an intensive outpatient management strategy (IOMS) of RA improved clinical outcomes measures (Grigor C, et al.). Indeed, the results from this clinical trial have shown that strict control and intense follow up, which are based on titration of treatment in accordance to a standardized protocol, improved disease activity, physical function and quality of life of patients without additional cost.

The proposed study will evaluate the application of two types of IOMS. The first IOMS will consist of titration of treatments based on the attainment of a DAS28 score under 2.4 (DAS28-IOMS). The second IOMS will consist of titration of treatment based on the attainment of zero swollen joints (0SJ-IOMS) (28 joints evaluated). Investigators should aim at achieving those targets within a reasonable period of time, i.e. during the first six months of treatment with adalimumab. In addition, investigators should aim at attaining these targets within reasonable limits for each individual patient. The clinical impact of these two IOMS will be compared to that of routine care (RC).

The results of this study will have significant implications not only for the individual subjects but also from the societal perspective since it may enhance the overall real-life effectiveness of the treatments and will identify the best approach to maximize on the benefits of treatment with HUMIRA®.

Primary Objective:

In patients with RA that are initiated on treatment with adalimumab:

The primary aim of the current study will be to assess the effect of two IOMS versus RC on the outcomes of patients with RA that are treated with adalimumab. The secondary aim will be to assess the differential effect of a DAS28-IOMS and a 0SJ-IOMS in this patient population.

Secondary Objectives:

In patients with RA that are initiated on treatment with adalimumab:

To compare the therapeutic effectiveness of DAS28-IOMS, 0SJ-IOMS and RC as measured by the proportion of subjects achieving target scores of the DAS28.
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on patient subjective assessment of functional status as measured by the Health Assessment Questionnaire (HAQ).
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on patients' perception of their disease as evaluated by the Work Limitation Questionnaire (WLQ).
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on patients' satisfaction with care as evaluated by the change of patients' satisfaction measured on a Likert scale.
To compare the therapeutic effectiveness of DAS28-IOMS, 0SJ-IOMS and RC as measured by the proportion of subjects achieving good or moderate European League against Rheumatism (EULAR) responses.
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on the frequency of serious adverse events or protocol-specified adverse events.

Tertiary Study Objectives:

In patients with RA that are initiated on treatment with adalimumab:

To compare the therapeutic effectiveness of DAS28-IOMS, 0SJ-IOMS and RC as measured by the proportion of subjects achieving target scores of the CDAI and the SDAI.
To describe the impact of individual components of the DAS28 on clinical decisions regarding patient management.
To describe the impact of the CDAI on clinical decisions regarding patient management.
To describe the impact of the SDAI on clinical decisions regarding patient management.
To describe the impact of the HAQ on clinical decisions regarding patient management.
To describe and compare the impact of a DAS28-IOMS, 0SJ-IOMS and RC on patients' compliance to treatment.
To describe and compare the impact of a DAS28-IOMS, 0SJ-IOMS and RC on changes in concomitant anti-rheumatic medication use.

Conditions: Rheumatoid Arthritis (RA)
Being tested: DAS28-IOMS, 0SJ-IOMS, Routine Care (RC)
Keywords: Rheumatoid Arthritis (RA), Anti-TNF therapy, Adalimumab, Disease activity, Treating to target
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

DAS28-IOMSOther
Investigators randomized to DAS28-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a DAS28 score of < 2.4.
0SJ-IOMSOther
Investigators randomized to 0SJ-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a swollen joint count of 0.
Routine Care (RC)Other
Investigators randomized to RC will NOT be expected to adapt their therapeutic approaches to a pre-defined target. They will optimize adalimumab treatment according to individual patient's responses to treatment as per routine care and according to their own judgment.

Study groups in NCT01585064
Study group	Role	What they receive
DAS28-IOMS		Physicians randomized to the DAS28-IOMS will treat patients according to a protocol aimed at achieving a DAS28 score under 2.4. Receives: Other: DAS28-IOMS
0SJ-IOMS		Physicians randomized to the 0SJ-IOMS will treat patients according to a protocol aimed at attaining a count of zero swollen joint (28 joints evaluated). Receives: Other: 0SJ-IOMS
Routine Care (RC)		Physicians randomized to the RC group will treat study patients as per routine care and according to their own judgment. Receives: Other: Routine Care (RC)

What is being measured

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

Change in Disease Activity as measured by the DAS28 after 12 months of treatment
The change in DAS28 will be calculated as an absolute and percent value. The percent change in DAS28 will the calculated as [DAS28M12 - DAS28M0) / (DAS28M0} x 100% where: DAS28M12 is the DAS28 score at 12 months and - DAS28M0 is the DAS28 score at baseline.
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0) and Month 12

Secondary outcomes (14)

Absolute and percent change in DAS28
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12 and Month 18 (Study end)
Absolute and percent change in the Health Assessment Questionnaire (HAQ)
The HAQ is a self-administered questionnaire to asses patient's health assessment and disability related to RA. The eight categories assessed by the HAQ are 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip, and 8) common daily activities. For each of these categories, patients report the amount of difficulty they have in performing two or three specific activities. The HAQ score is the average of the worst score in each of the eight categories. The total score ranges from 0-3.
Measured: Baseline (0), Month 6, Month 12 and Month 18 (Study end)
Absolute and percent change in individual components of the DAS28
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percent achieving clinical remission defined as a DAS28 < 2.6
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving clinical remission as measured by the DAS28 <2.6
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percent achieving a DAS28 < 3.2
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving a DAS28 <3.2
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percent achieving a DAS28<2.4
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving a DAS28<2.4
The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percentage achieving good or moderate European League Against Rheumatism (EULAR) responses
EULAR response criteria using DAS28 Score
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving good or moderate EULAR responses
EULAR response criteria using DAS28 Score
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Patient Satisfaction with Care
A Likert scale will be used to evaluate the patient's satisfaction with care at each visit.
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Absolute and percent change in the Work Limitations Questionnaire (WLQ)
The WLQ is used to measure the impairment in work related productivity, with reference to the previous two weeks.
Measured: Baseline (0), Month 6, Month 12 and Month 18 (Study end)
Incidence of adverse events / serious adverse events
All adverse events will be coded according to the MedDRA dictionary of terms and will be classified according to causal association to adalimumab (HUMIRA®). All events will be reported by body system using MedDRA preferred terms. The incidence rates of adverse events will be described as the proportion of subjects experiencing at least one event and as the number of events per patient.
Measured: Baseline (0), Month 6, Month 12, Month 18 (Study End)

Timeline

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

Aug 2006Feb 2010

First posted25 Apr 2012 (estimated)
Study startAug 2006
Primary completionDec 2009
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01585064
Sponsor's protocol ID: A06-216
Other IDs: HUM-05-081
Status last verified: Apr 2012
First submitted: 23 Apr 2012
Last updated: 25 Apr 2012
Results posted: No
Data monitoring committee: Yes

Publications

Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001 Sep 15;358(9285):903-11. doi: 10.1016/S0140-6736(01)06075-5.
PubMed 11567728
Pincus T, Callahan LF. Taking mortality in rheumatoid arthritis seriously--predictive markers, socioeconomic status and comorbidity. J Rheumatol. 1986 Oct;13(5):841-5. No abstract available.
PubMed 3820193
Badley EM, Rasooly I, Webster GK. Relative importance of musculoskeletal disorders as a cause of chronic health problems, disability, and health care utilization: findings from the 1990 Ontario Health Survey. J Rheumatol. 1994 Mar;21(3):505-14.
PubMed 8006895
Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, Kincaid W, Porter D. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004 Jul 17-23;364(9430):263-9. doi: 10.1016/S0140-6736(04)16676-2.
PubMed 15262104
Pope JE, Haraoui B, Rampakakis E, Psaradellis E, Thorne C, Sampalis JS; Optimization of Adalimumab Trial Investigators. Treating to a target in established active rheumatoid arthritis patients receiving a tumor necrosis factor inhibitor: results from a real-world cluster-randomized adalimumab trial. Arthritis Care Res (Hoboken). 2013 Sep;65(9):1401-9. doi: 10.1002/acr.22010.
PubMed 23509040
Pope J, Thorne JC, Haraoui BP, Psaradellis E, Sampalis J. Do patients with active RA have differences in disease activity and perceptions if anti-TNF naive versus anti-TNF experienced? Baseline results of the optimization of adalimumab trial. Med Sci Monit. 2012 Aug;18(8):PI17-20. doi: 10.12659/msm.883250.
PubMed 22847212

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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimization of Treatment With Adalimumab (HUMIRA): A Multi-center, Randomized, Single Blind, Controlled Clinical Trial
ClinicalTrials.gov ID: NCT01585064
Acronym / sponsor ID: A06-216
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid Arthritis (RA), Anti-TNF therapy, Adalimumab, Disease activity, Treating to target
Study type: Observational
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
Collaborators: Abbott
Study start: Aug 2006
Primary completion: Dec 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 25 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Background:

Primary Objective:

In patients with RA that are initiated on treatment with adalimumab:

The primary aim of the current study will be to assess the effect of two IOMS versus RC on the outcomes of patients with RA that are treated with adalimumab. The secondary aim will be to assess the differential effect of a DAS28-IOMS and a 0SJ-IOMS in this patient population.

Secondary Objectives:

In patients with RA that are initiated on treatment with adalimumab:

To compare the therapeutic effectiveness of DAS28-IOMS, 0SJ-IOMS and RC as measured by the proportion of subjects achieving target scores of the DAS28.
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on patient subjective assessment of functional status as measured by the Health Assessment Questionnaire (HAQ).
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on patients' perception of their disease as evaluated by the Work Limitation Questionnaire (WLQ).
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on patients' satisfaction with care as evaluated by the change of patients' satisfaction measured on a Likert scale.
To compare the therapeutic effectiveness of DAS28-IOMS, 0SJ-IOMS and RC as measured by the proportion of subjects achieving good or moderate European League against Rheumatism (EULAR) responses.
To compare the impact of DAS28-IOMS, 0SJ-IOMS and RC on the frequency of serious adverse events or protocol-specified adverse events.

Tertiary Study Objectives:

In patients with RA that are initiated on treatment with adalimumab:

To compare the therapeutic effectiveness of DAS28-IOMS, 0SJ-IOMS and RC as measured by the proportion of subjects achieving target scores of the CDAI and the SDAI.
To describe the impact of individual components of the DAS28 on clinical decisions regarding patient management.
To describe the impact of the CDAI on clinical decisions regarding patient management.
To describe the impact of the SDAI on clinical decisions regarding patient management.
To describe the impact of the HAQ on clinical decisions regarding patient management.
To describe and compare the impact of a DAS28-IOMS, 0SJ-IOMS and RC on patients' compliance to treatment.
To describe and compare the impact of a DAS28-IOMS, 0SJ-IOMS and RC on changes in concomitant anti-rheumatic medication use.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
DAS28-IOMS	–	Other: DAS28-IOMSPhysicians randomized to the DAS28-IOMS will treat patients according to a protocol aimed at achieving a DAS28 score under 2.4.
0SJ-IOMS	–	Other: 0SJ-IOMSPhysicians randomized to the 0SJ-IOMS will treat patients according to a protocol aimed at attaining a count of zero swollen joint (28 joints evaluated).
Routine Care (RC)	–	Other: Routine Care (RC)Physicians randomized to the RC group will treat study patients as per routine care and according to their own judgment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients will be recruited from approximately 40 sites across Canada. The study sample selection will be stratified in order to ensure adequate representation from all Canadian regions.

Key inclusion criteria (11 listed)

Patient has a diagnosis of rheumatoid arthritis
Patient is > 18 years of age
Patient is naïve to HUMIRA® (adalimumab) therapy.
Patient has access to reimbursement for their standard of care.
If female, patient is either: 1) not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or 2) of childbearing potential and practicing one of the following methods of birth control:

Key exclusion criteria (9 listed)

Patients had a history of cancer within the past 5 years other than a successfully treated basal cell carcinoma and/or localized carcinoma in situ of the cervix
Patients with a history either of lymphoma or leukemia.
Patients with a history of untreated active tuberculosis, or listeriosis, or other currently active infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic protozoal or fungal infections.
Patients with a known positive HIV test.
Patients with a known positive HepBsAg test.

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
DAS28-IOMSInvestigators randomized to DAS28-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a DAS28 score of < 2.4.	Other	DAS28-IOMS
0SJ-IOMSInvestigators randomized to 0SJ-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a swollen joint count of 0.	Other	0SJ-IOMS
Routine Care (RC)Investigators randomized to RC will NOT be expected to adapt their therapeutic approaches to a pre-defined target. They will optimize adalimumab treatment according to individual patient's responses to treatment as per routine care and according to their own judgment.	Other	Routine Care (RC)

Primary outcome

Change in Disease Activity as measured by the DAS28 after 12 months of treatment
Time frame: Baseline (0) and Month 12
The change in DAS28 will be calculated as an absolute and percent value. The percent change in DAS28 will the calculated as [DAS28M12 - DAS28M0) / (DAS28M0} x 100% where: DAS28M12 is the DAS28 score at 12 months and - DAS28M0 is the DAS28 score at baseline. The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).

14 secondary outcomes

Absolute and percent change in DAS28
Time frame: Baseline (0), Month 6, Month 12 and Month 18 (Study end)
Absolute and percent change in the Health Assessment Questionnaire (HAQ)
Time frame: Baseline (0), Month 6, Month 12 and Month 18 (Study end)
Absolute and percent change in individual components of the DAS28
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percent achieving clinical remission defined as a DAS28 < 2.6
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving clinical remission as measured by the DAS28 <2.6
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percent achieving a DAS28 < 3.2
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving a DAS28 <3.2
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percent achieving a DAS28<2.4
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving a DAS28<2.4
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Percentage achieving good or moderate European League Against Rheumatism (EULAR) responses
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Time to achieving good or moderate EULAR responses
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Patient Satisfaction with Care
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)
Absolute and percent change in the Work Limitations Questionnaire (WLQ)
Time frame: Baseline (0), Month 6, Month 12 and Month 18 (Study end)
Incidence of adverse events / serious adverse events
Time frame: Baseline (0), Month 6, Month 12, Month 18 (Study End)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
Background: PubMed 11567728Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001 Sep 15;358(9285):903-11. doi: 10.1016/S0140-6736(01)06075-5.
Background: PubMed 3820193Pincus T, Callahan LF. Taking mortality in rheumatoid arthritis seriously--predictive markers, socioeconomic status and comorbidity. J Rheumatol. 1986 Oct;13(5):841-5. No abstract available.
Background: PubMed 8006895Badley EM, Rasooly I, Webster GK. Relative importance of musculoskeletal disorders as a cause of chronic health problems, disability, and health care utilization: findings from the 1990 Ontario Health Survey. J Rheumatol. 1994 Mar;21(3):505-14.
Background: PubMed 15262104Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, Kincaid W, Porter D. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004 Jul 17-23;364(9430):263-9. doi: 10.1016/S0140-6736(04)16676-2.
Derived from this study: PubMed 23509040Pope JE, Haraoui B, Rampakakis E, Psaradellis E, Thorne C, Sampalis JS; Optimization of Adalimumab Trial Investigators. Treating to a target in established active rheumatoid arthritis patients receiving a tumor necrosis factor inhibitor: results from a real-world cluster-randomized adalimumab trial. Arthritis Care Res (Hoboken). 2013 Sep;65(9):1401-9. doi: 10.1002/acr.22010.
Derived from this study: PubMed 22847212Pope J, Thorne JC, Haraoui BP, Psaradellis E, Sampalis J. Do patients with active RA have differences in disease activity and perceptions if anti-TNF naive versus anti-TNF experienced? Baseline results of the optimization of adalimumab trial. Med Sci Monit. 2012 Aug;18(8):PI17-20. doi: 10.12659/msm.883250.

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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.

Janet E Pope, MD MPH FRCPC principal investigator

Lawson Health Research Institute, Western University

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 (RA), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

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 11 inclusion and 9 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 25 Apr 2012. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in Disease Activity as measured by the DAS28 after 12 months of treatment (time frame: Baseline (0) and Month 12). 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 NCT01585064, which also lists 6 linked publications.

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 25 Apr 2012.