Trial Outcomes & Findings for 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 (NCT NCT01083160)

Last Updated: 2012-01-19

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

82 participants

Primary outcome timeframe

Baseline and Weeks 8,16 and 24

Results posted on

2012-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	82
Overall Study Evaluable Population	71
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non Responders to Other Anti-TNF n=82 Participants 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.
Age Continuous	48.34 years STANDARD_DEVIATION 11.56 • n=5 Participants
Sex/Gender, Customized Female	66 participants n=5 Participants
Sex/Gender, Customized Male	13 participants n=5 Participants
Sex/Gender, Customized Gender not reported	3 participants n=5 Participants
Region of Enrollment Mexico	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Weeks 8,16 and 24

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

Outcome measures

Outcome measures
Measure	Non Responders to Other Anti-TNF n=82 Participants 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.
DAS28 (Disease Activity Score in 28 Joints) DAS 28 at Week 8 (n=80)	4.63 units on a scale Standard Deviation 1.77
DAS28 (Disease Activity Score in 28 Joints) DAS 28 at Week 16 (n=79)	4.05 units on a scale Standard Deviation 1.74
DAS28 (Disease Activity Score in 28 Joints) DAS 28 at Week 24 (n=71)	3.68 units on a scale Standard Deviation 1.47
DAS28 (Disease Activity Score in 28 Joints) DAS 28 at Baseline (n=82)	6.04 units on a scale Standard Deviation 1.17

PRIMARY outcome

Timeframe: Baseline and Weeks 8,16 and 24

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

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.

Outcome measures

Outcome measures
Measure	Non Responders to Other Anti-TNF n=82 Participants 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.
Tender Joint Count and Swollen Joint Count Tender joints at Baseline (n=82)	13.05 Joints Standard Deviation 7.29
Tender Joint Count and Swollen Joint Count > Week 8 (n=80)	7.16 Joints Standard Deviation 6.37
Tender Joint Count and Swollen Joint Count >Week 16 (n=80)	3.15 Joints Standard Deviation 4.67
Tender Joint Count and Swollen Joint Count >Week 24 (n=71)	2.52 Joints Standard Deviation 4.10
Tender Joint Count and Swollen Joint Count Swollen joints at Baseline (n=82)	9.56 Joints Standard Deviation 5.97
Tender Joint Count and Swollen Joint Count >Week 8 (n=80)	4.48 Joints Standard Deviation 4.68

PRIMARY outcome

Timeframe: Baseline and Weeks 8,16 and 24

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

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.

Outcome measures

Outcome measures
Measure	Non Responders to Other Anti-TNF n=82 Participants 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.
Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) VAS at Baseline (n=82)	62.88 Units on a scale Standard Deviation 22.31
Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) >Week 8 (n=80)	39.69 Units on a scale Standard Deviation 25.40
Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) >Week 16 (n=80)	32.35 Units on a scale Standard Deviation 26.02
Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) >Week 24 (n=71)	28.70 Units on a scale Standard Deviation 23.32

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Analysis population included all participants enrolled in the study who took at least one dose of 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.

Outcome measures

Outcome measures
Measure	Non Responders to Other Anti-TNF n=82 Participants 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.
Evaluate the Compliance and Clinical Tolerability With Adalimumab Reported 1 missed dose at Week 8	1 Participants
Evaluate the Compliance and Clinical Tolerability With Adalimumab Reported 2 missed doses at Week 8	3 Participants
Evaluate the Compliance and Clinical Tolerability With Adalimumab Reported 3 missed doses at Week 16	1 Participants
Evaluate the Compliance and Clinical Tolerability With Adalimumab Reported 2 missed doses at Week 16	1 Participants
Evaluate the Compliance and Clinical Tolerability With Adalimumab Experienced a non-serious adverse event	6 Participants
Evaluate the Compliance and Clinical Tolerability With Adalimumab Experienced a serious adverse event	1 Participants

Adverse Events

Non Responders to Other Anti-TNF

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non Responders to Other Anti-TNF n=82 participants at risk 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.
Gastrointestinal disorders rectal bleeding	1.2% 1/82 • Number of events 1 • 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

Other adverse events
Measure	Non Responders to Other Anti-TNF n=82 participants at risk 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.
Gastrointestinal disorders Constipation	1.2% 1/82 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	1.2% 1/82 • Number of events 1 • 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.
General disorders Asthenia	1.2% 1/82 • Number of events 1 • 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.
General disorders Chills	1.2% 1/82 • Number of events 1 • 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.
General disorders Phosphenes	1.2% 1/82 • Number of events 1 • 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.
General disorders Pain	1.2% 1/82 • Number of events 1 • 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.
Infections and infestations Upper respiratory tract infection	2.4% 2/82 • Number of events 2 • 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.
Injury, poisoning and procedural complications Swelling in administration site	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Rhinorrea	1.2% 1/82 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Sneezing	1.2% 1/82 • Number of events 1 • 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.
Vascular disorders Hypertension	1.2% 1/82 • Number of events 1 • 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.

Additional Information

Global Medical Services

Abbott

Phone: 1-800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection
Publication restrictions are in place

Restriction type: OTHER