Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: Rituximab; Drug: Atacicept; Drug: Placebo matched to atacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664521

28155

Details and patient eligibility

About

The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects
• Greater than and equal to (>=) 18 years of age at the time of Informed Consent
• Who have rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 12 months
• Subjects must have active disease defined by DAS28 >3.2
• Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab
• Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before study day 1 (SD1), during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and SD1
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Current neurological disease excluding migraine
• Inflammatory joint disease other than rheumatoid arthritis
• Any contraindication to rituximab as per national label
• Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen >25 mg/week
• Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer)
• Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1
• Active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before SD1
• Serum Immunoglobulin G (IgG) below 6 gram per liter (g/L)
• Known hypersensitivity to atacicept or to any of the components of the formulated atacicpet
• Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins
• Breastfeeding or pregnancy
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Rituximab Plus Atacicept

Experimental group

Description:

Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.

Treatment:

Drug: Atacicept

Biological: Rituximab

Rituximab Plus Placebo

Placebo Comparator group

Description:

Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.

Treatment:

Drug: Placebo matched to atacicept

Biological: Rituximab