Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Abbott

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00647270

M10-261

Details and patient eligibility

About

To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

Full description

The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject > 18 years of age
• Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months
• Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed
• If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment
• Subject is judged to be in generally good health as determined by the principal investigator

Exclusion criteria

• Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab
• Subject has a history of acute inflammatory joint disease of different origin other than RA
• Subject has been treated with any investigational biologic agents
• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast-feeding or considering becoming pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo 12 weeks, 40mg adalimumab remaining 12 weeks

Treatment:

Drug: Placebo

40 mg

Active Comparator group

Description:

40 mg every other week

Treatment:

Drug: adalimumab

Drug: adalimumab

80 mg

Active Comparator group

Description:

80 mg monthly

Treatment:

Drug: adalimumab

Drug: adalimumab