Clinical trial NCT01783730: 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
Official title: Special Investigation in Japanese Rheumatoid Arthritis Patients Who Have no Previous Use of DMARDs and Biological Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 163
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This was a multicenter, prospective, observational study of adalimumab. Each participant enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until discontinuation of the drug.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

There were no specific exclusion criteria.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From baseline through week 26
Secondary outcomes:
measure: Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline
timeFrame: at week 0
measure: Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4
timeFrame: at week 4
measure: Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12
timeFrame: at week 12
measure: Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24
timeFrame: at week 24
measure: Percentage of Participants Achieving DAS28-4(ESR) Remission
timeFrame: From baseline to 24 weeks
measure: Mean Clinical Disease Activity Index (CDAI) Score at Baseline
timeFrame: at week 0
measure: Mean Clinical Disease Activity Index (CDAI) Score at Week 4
timeFrame: at week 4
measure: Mean Clinical Disease Activity Index (CDAI) Score at Week 12
timeFrame: at week 12
measure: Mean Clinical Disease Activity Index (CDAI) Score at Week 24
timeFrame: at week 24
measure: Percentage of Participants Achieving CDAI Remission
timeFrame: From baseline to 24 weeks
measure: Mean Simplified Disease Activity Index (SDAI) Score at Baseline
timeFrame: at week 0
measure: Mean Simplified Disease Activity Index (SDAI) Score at Week 4
timeFrame: at week 4
measure: Mean Simplified Disease Activity Index (SDAI) Score at Week 12
timeFrame: at week 12
measure: Mean Simplified Disease Activity Index (SDAI) Score at Week 24
timeFrame: at week 24
measure: Percentage of Participants Achieving SDAI Remission
timeFrame: From baseline to 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Sarina Kurimoto, MD
role: STUDY_DIRECTOR
References:
citation: 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.