Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice

NCT01736189 | Completed Results DMC

• 1 other identifier: P13-684
• Study Type: observational
• Target: 346
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a single-arm, multicenter, open label, prospective cohort study (post-marketing observational study) to determine the effectiveness and safety of adalimumab in combination with high-dose methotrexate (≥12 mg/week) in participants with rheumatoid arthritis in a routine clinical setting in Japan.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Methotrexate

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52

  The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hr) or C-reactive protein (CRP; mg/dL) level, and the participant's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.

  At Week 52

Secondary Outcomes (5)

• Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score ≤ 2.8 at Week 104

  At Week 104

• Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score ≤ 3.3 at Week 104

  At Week 104

• Percentage of Participants With a Health Assessment Questionnaire Disability Index (HAQ-DI) Score < 0.5 at Week 104

  At Week 104

• Mean Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 104

  Baseline and Week 104

• Percentage of Participants With a Change From Baseline of ≤ 1.0 in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 104

  Baseline and Week 104

Study Arms (1)

Participants treated with adalimumab

40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks

Drug: Adalimumab

Interventions

Adalimumab DRUG

Pre-filled syringe, administered by subcutaneous injection

Also known as: Humira, ABT-D2E7

Participants treated with adalimumab

Eligibility Criteria

• Age: 16 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

Participants with rheumatoid arthritis treated in a daily clinical setting, who received adalimumab (and high dose methotrexate \[≥12 mg/week\]), were observed prospectively.

You may qualify if:

• The participants of this study were rheumatoid arthritis (RA) patients for whom adalimumab was prescribed. They must have met the following conditions:
• Disease duration of RA ≤2 years
• Methotrexate (MTX) administration ≥3 months prior to starting adalimumab
• Dose of MTX ≥12mg/week
• Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) score \>3.2

You may not qualify if:

• Participants who had been previously treated with biologics (including tumor necrosis factor \[TNF\] inhibitors and others)

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (1)

• Tanaka Y, Mimori T, Yamanaka H, Sunaga N, Morita K, Kimura J, Takeuchi T. Effectiveness, safety, and methotrexate dose-tapering pattern over two years of treatment with adalimumab and >/=12 mg/week methotrexate for early rheumatoid arthritis: Results of the HAWK postmarketing surveillance study in Japan. Mod Rheumatol. 2020 May;30(3):424-433. doi: 10.1080/14397595.2019.1639931. Epub 2019 Jul 22.

  PMID: 31267801 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  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: November 27, 2012
• First Posted: November 29, 2012
• Study Start: October 11, 2012
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06