Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— August III  

Official title:

A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664521
• Other study ID #: 28155
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2008
• Last updated: April 4, 2012
• Start date: March 2008
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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 receiving re-treatment with rituximab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects

• >18 years of age at the time of Informed Consent

• who have rheumatoid arthritis (satisfying American College of Rheumatology criteria)

• a disease history of at least 12 months.

• Subjects must have active disease defined by

• >8 swollen joints (out of 66)

• >8 tender joints (out of 68)

• CRP >6 mg/L

• ESR >28 mm/h.

• 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 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.

Exclusion Criteria:

• Neurological disease

• 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 IgG below 6 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Rituximab
Rituximab 1000 mg IV infusion, 2nd 1000 mg IV infusion given 2 weeks later, followed 28 days later by atacicept/placebo 150 mg/mL SC once weekly for 25 weeks
• Atacicept / placebo
Atacicept/placebo 150 mg/mL SC once weekly for 25 weeks, given in combination with rituximab 1000 mg IV infusion on study day 10, 2nd 1000 mg IV infusion given 2 weeks later

Locations

Country	Name	City	State
France	Research Site	Nice
France	Research Site	Paris
France	Research Site	Strasbourg
Netherlands	Research Site	Amsterdam
Sweden	Research Site	Malmö
Sweden	Research Site	Stockholm
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Countries where clinical trial is conducted

France,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nature, incidence and severity of adverse events (AEs)		Every 2 - 6 weeks	Yes
Primary	Proportion of subjects who develop IgG <3 g/L		Every 2 - 6 weeks	Yes
Primary	Changes / abnormalities in vital signs/ routine safety lab parameters		Every 2 - 6 weeks	Yes
Primary	Changes over time in vaccine immunization status		Every 2 - 6 weeks	Yes
Secondary	ACR and DAS28 composite scores at week 26		Every 2 - 6 weeks	Yes