Clinical trial NCT01163318: Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis
Official title: Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 552
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.

Brief 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.

Detailed description: Rheumatoid arthritis is a chronic autoimmune disease which requires long-term treatment. Due to the need of long-term safety data in Japanese participants and to fulfil the conditions of approval of adalimumab by the Japanese regulatory authority, this post-marketing observational study (PMOS) was conducted. The study investigated the long-term safety of adalimumab, particularly associated with the development of infections and malignant tumors. Data was collected once every 6 months up to 3 years.

Eligibility criteria: Inclusion criteria:

1. Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.
2. Participants who used adalimumab continuously.
3. Participants without current or past history of malignant tumors.
4. Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR).
5. 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:

1. Contraindications according to the package insert.
2. Participants with serious infections.
3. Participants with tuberculosis.
4. Participants with a history of hypersensitivity to any ingredient of adalimumab.
5. Participants with demyelinating disease or a history of demyelinating disease.
6. Participants with congestive cardiac failure.

Primary outcomes:
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: From the initiation of adalimumab treatment, every 6 months up to 3 years.
Secondary outcomes:
measure: Incidence of Infections and Malignant Tumors
timeFrame: From the initiation of adalimumab treatment, every 6 months up to 3 years.
measure: Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit
timeFrame: Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3
measure: Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit
timeFrame: Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Sarina Kurimoto
role: STUDY_DIRECTOR
References: