N/A
N=552
Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01163318 ↗Enrolled (actual)
552
Serious AEs
16.9%
Results posted
Jun 2015
Primary outcome: Primary: Incidence of Adverse Drug Reactions (ADRs) — 33.3 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Drug Reactions (ADRs) |
33.3 | — |
| SECONDARY Incidence of Infections and Malignant Tumors |
16.1; 1.2 | — |
| SECONDARY Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit |
2.8; 14.5; 20.0; 29.6; 33.6; 37.1 | — |
| SECONDARY Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit |
43.4; 53.5; 63.6; 63.6; 66.0; 65.7 | — |
Summary
The purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the drug for the treatment of rheumatoid arthritis.
Eligibility Criteria
Inclusion criteria
- Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.
- Participants who used adalimumab continuously.
- Participants without current or past history of malignant tumors.
- Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR).
- Participants evaluated by Health Assessment Questionnaire (HAQ) or Modified Health Assessment Questionnaire (MHAQ) prior to the initiation of adalimumab treatment in the all-case PMOS.
Exclusion criteria
- Contraindications according to the package insert.
- Participants with serious infections.
- Participants with tuberculosis.
- Participants with a history of hypersensitivity to any ingredient of adalimumab.
- Participants with demyelinating disease or a history of demyelinating disease.
- Participants with congestive cardiac failure.
Data sourced from ClinicalTrials.gov (NCT01163318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.