Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00234884

Acronym

ReAlise

Enrollment

3435

Registered

2005-10-10

Start date

2003-09-30

Completion date

2010-07-31

Last updated

2011-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, adalimumab

Brief summary

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Detailed description

This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634). Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Interventions

BIOLOGICALadalimumab

commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC). * Participants must have been willing to consent to data being collected and provided to Abbott.

Exclusion criteria

· Participants with contraindications according to the SmPC.

Design outcomes

Primary

Measure	Time frame	Description
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.
American College of Rheumatology 20% (ACR20) Response Rate	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
American College of Rheumatology 50% (ACR50) Response Rate	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
American College of Rheumatology 70% (ACR70) Response Rate	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).

Countries

Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom

Participant flow

Participants by arm

Arm	Count
Adalimumab Participants were treated with commercially available adalimumab in normal clinical practice.	3,435
Total	3,435

Baseline characteristics

Characteristic	Adalimumab
Age Continuous	54.5 years STANDARD_DEVIATION 12.5
Region of Enrollment Australia	20 participants
Region of Enrollment Austria	95 participants
Region of Enrollment Belgium	318 participants
Region of Enrollment France	689 participants
Region of Enrollment Germany	561 participants
Region of Enrollment Greece	232 participants
Region of Enrollment Italy	672 participants
Region of Enrollment Netherlands	248 participants
Region of Enrollment Portugal	55 participants
Region of Enrollment Spain	476 participants
Region of Enrollment United Kingdom	69 participants
Sex: Female, Male Female	2724 Participants
Sex: Female, Male Male	711 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	562 / 3,435
serious Total, serious adverse events	755 / 3,435

Outcome results

Primary

American College of Rheumatology 20% (ACR20) Response Rate

ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).