Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis

NCT01163318 | Completed Results

• 1 other identifier: P12-070
• Study Type: observational
• Target: 552
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Drug Reactions (ADRs)

  An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.

  From the initiation of adalimumab treatment, every 6 months up to 3 years.

Secondary Outcomes (3)

• Incidence of Infections and Malignant Tumors

  From the initiation of adalimumab treatment, every 6 months up to 3 years.

• Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit

  Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3

• Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit

  Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3

Study Arms (1)

Adalimumab 40 mg/0.8 mL syringe for subcutaneous injection

Participants with rheumatoid arthritis who received adalimumab, per approved label

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Sarina Kurimoto

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: December 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-05