Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

NCT01783730 | Completed Results

• 1 other identifier: P13-983
• Study Type: observational
• Target: 163
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.

  From baseline through week 26

Secondary Outcomes (15)

• Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline

  at week 0

• Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4

  at week 4

• Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12

  at week 12

• Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24

  at week 24

• Percentage of Participants Achieving DAS28-4(ESR) Remission

  From baseline to 24 weeks

Study Arms (1)

Participants with high rheumatoid arthritis disease activity

Participants who received adalimumab treatment

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid Arthritis participants showing rapid progression of structural damage of the joints, who have no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

You may qualify if:

• High disease activity, with poor prognostic factors (e.g., rheumatoid factor \[RF\]-positive, anti-cyclic citrullinated peptide \[CCP\] antibody-positive, or bone erosion)
• Combination of adalimumab and methotrexate will be started
• No prior history of treatment with disease-modifying anti-rheumatic drugs
• No prior history of treatment with biological agents
• Adalimumab dosed according to the registered product label
• Signed informed consent

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Ito Y, Hozumi K, Okada Y, Kurimoto S. Adalimumab with Methotrexate in Treatment-Naive Japanese Patients with Rheumatoid Arthritis at Risk of Progressive Structural Joint Damage: A Postmarketing Observational Study. Rheumatol Ther. 2017 Jun;4(1):151-166. doi: 10.1007/s40744-017-0059-1. Epub 2017 Mar 31.

  PMID: 28364381 DERIVED

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 Services
• Organization: AbbVie

800-633-9110

Study Officials

• Sarina Kurimoto, MD

  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: February 1, 2013
• First Posted: February 5, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 26, 2016
• Results First Posted: October 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share