Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

NCT00691028 | Completed Phase 3 Results

• 2 other identifiers: TA-650-13JapicCTI-050146
• Study Type: interventional
• Target: 327
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; RA; Infliximab; TA-650; Remicade

Outcome Measures

Primary Outcomes (1)

• Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)

  The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient's assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient's global assessment of disease activity (VAS 0-100); c. Physician's global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.

  baseline and week 54

Secondary Outcomes (9)

• Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)

  54 weeks

• Tender Joint Counts (TJC)

  54 weeks

• Swollen Joint Count (SJC)

  54 weeks

• CRP Level

  54 weeks

• Change From Baseline in DAS28

  baseline and week 54

Study Arms (3)

TA-650 3 mg/kg

EXPERIMENTAL

Drug: TA-650 3 mg/kg

TA-650 6 mg/kg

EXPERIMENTAL

Drug: TA-650 6 mg/kg

TA-650 10 mg/kg

EXPERIMENTAL

Drug: TA-650 10 mg/kg

Interventions

TA-650 10 mg/kg DRUG

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

Also known as: Infliximab, REMICADE

TA-650 10 mg/kg

TA-650 3 mg/kg DRUG

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

Also known as: Infliximab, REMICADE

TA-650 3 mg/kg

TA-650 6 mg/kg DRUG

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

Also known as: Infliximab, REMICADE

TA-650 6 mg/kg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with active RA in spite of stable dose of MTX

You may not qualify if:

• Having received infliximab in the past
• Having a history of serious infection which caused hospitalization within 6 months before the registration
• Having an active tuberculosis
• Having a complication or a history of malignancy within 5 years before the registration

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Related Publications (2)

• Takeuchi T, Miyasaka N, Inoue K, Abe T, Koike T; RISING study. Impact of trough serum level on radiographic and clinical response to infliximab plus methotrexate in patients with rheumatoid arthritis: results from the RISING study. Mod Rheumatol. 2009;19(5):478-87. doi: 10.1007/s10165-009-0195-8. Epub 2009 Jul 22.

  PMID: 19626391 BACKGROUND

• Takeuchi T, Miyasaka N, Inui T, Yano T, Yoshinari T, Abe T, Koike T. High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study. Arthritis Res Ther. 2017 Sep 2;19(1):194. doi: 10.1186/s13075-017-1401-2.

  PMID: 28865493 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: September 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: January 7, 2026
• Results First Posted: May 20, 2013

Record last verified: 2025-12