RESTART C0168Z05 Rheumatoid Arthritis Study

NCT ID: NCT00714493

Last Updated: 2013-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

Detailed Description

This is a Phase 4, multi center, open-label, assessor blinded, switch study of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate response to their current treatment with etanercept or adalimumab. The last dose of etanercept must have been at least 1 week but not more than 2 weeks prior to the first infliximab study infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab study infusion. The study will be conducted for 30 weeks and will include 200 patients. All eligible patients will receive 3 mg/kg infliximab infusions (drug given into a vein) at weeks 0, 2, and 6 and every 8 weeks thereafter, if they achieve a European League Against Rheumatism (EULAR) response on their current dose of infliximab. Patients who do not achieve a EULAR response will increase their dose from 3mg/kg to 5 mg/kg at week 14. Patients who do not achieve a EULAR response at week 22 will increase from either 3 mg/kg to 5 mg/kg or from 5mg/kg to 7 mg/kg. The last study infusion will take place at week 22. The last study visit for effectiveness evaluations will take place at week 26. A week 30 follow-up visit will be performed for adverse events and tuberculosis evaluations, health economics assessments, and review of concomitant medications. All patients who end the study early will be required to complete all assessments. Patients will receive 3 mg/kg infliximab infusions at weeks 0, 2, and 6. If patients achieve European League Against Rheumatism (EULAR) response, they will remain on their current dose. Patients who do not demonstrate a EULAR response will increase their infliximab dose from 3 mg/kg to 5 mg/kg at week 14. At week 22, patients will also increase their infliximab dose from 3 mg/kg to 5mg/kg or from 5 mg/kg to 7mg/kg if they do not demonstrate a EULAR response.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; remicade; infliximab; Centocor; etanercept; enbrel; adalimumab; humira; restart; swollen joints; tender joints.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

Infliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

Group Type: OTHER

Infliximab

Intervention Type: BIOLOGICAL

3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

Interventions

Infliximab

3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients must have rheumatoid arthritis
• Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
• Patients must have inadequate disease response to etanercept or adalimumab
• Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

Exclusion Criteria

• Patients who have a history of latent or active TB
• Have inflammatory disease other than rheumatoid arthritis
• Have had a chronic or recurrent infectious disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Centocor Ortho Biotech Services, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor Ortho Biotech Services, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Centocor Ortho Biotech Services, L.L.C.

Locations

Huntsville, Alabama, United States

Paradise Valley, Arizona, United States

Tucson, Arizona, United States

Santa Monica, California, United States

Bridgeport, Connecticut, United States

Lewes, Delaware, United States

Boca Raton, Florida, United States

Palm Harbor, Florida, United States

Tamarac, Florida, United States

Vero Beach, Florida, United States

Atlanta, Georgia, United States

Moline, Illinois, United States

Springfield, Illinois, United States

Lexington, Kentucky, United States

Wheaton, Maryland, United States

Saint Clair Shores, Michigan, United States

Eagan, Minnesota, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Berkeley Heights, New Jersey, United States

Freehold, New Jersey, United States

Albany, New York, United States

Syracuse, New York, United States

Chapel Hill, North Carolina, United States

Columbus, Ohio, United States

Mayfield, Ohio, United States

Middleburg Heights, Ohio, United States

Tulsa, Oklahoma, United States

Allentown, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Wexford, Pennsylvania, United States

Charleston, South Carolina, United States

Greenville, South Carolina, United States

Jackson, Tennessee, United States

Nashville, Tennessee, United States

Amarillo, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Mesquite, Texas, United States

Temple, Texas, United States

Tyler, Texas, United States

Burke, Virginia, United States

Reston, Virginia, United States

Seattle, Washington, United States

Graz-Eggenberg, , Austria

Vienna, , Austria

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

St. John's, Newfoundland and Labrador, Canada

Toronto, Ontario, Canada

Hamilton Ontario, , Canada

Helsinki, , Finland

Bordeaux, , France

Limoges, , France

Montivilliers, , France

Orléans, , France

Frankfurt, , Germany

Holdenfelde, , Germany

Leipzig, , Germany

München, , Germany

Ratingen, , Germany

Ashkelon, , Israel

Beer Yaakov, , Israel

Haifa, , Israel

Kfar Saba, , Israel

Ramat Gan, , Israel

Rehovot, , Israel

Tel Aviv, , Israel

Alkmaar, , Netherlands

Madrid, , Spain

Oviedo, , Spain

Santiago de Compostela, , Spain

Leeds, , United Kingdom

London, , United Kingdom

Wigan, , United Kingdom

Countries

Belgium; United States; Austria; Canada; Finland; France; Germany; Israel; Netherlands; Spain; United Kingdom

References

Fleischmann R, Goldman JA, Leirisalo-Repo M, Zanetakis E, El-Kadi H, Kellner H, Bolce R, DeHoratius R, Wang J, Decktor D. Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study. Curr Med Res Opin. 2014 Nov;30(11):2139-49. doi: 10.1185/03007995.2014.942416. Epub 2014 Jul 30.

Reference Type: DERIVED

PMID: 25050591 (View on PubMed)

Other Identifiers

C0168Z05

Identifier Type: OTHER

Identifier Source: secondary_id

CR013879

Identifier Type: -

Identifier Source: org_study_id

NCT01281449

Identifier Type: -

Identifier Source: nct_alias