A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)

NCT00732875 | Completed Phase 3 Results

• 1 other identifier: P05645
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is extension part of the P04280 (placebo-controlled, double-blind, randomized study of chronic treatment with infliximab in approximately 140 patients, NCT00202852). This study will be conducted at 6 study centers in South Korea. After completion of the last follow-up visit at Week 30 and code break in main double-blind trial, subjects randomized to the placebo group and those who were treated with an infliximab-containing regimen who maintained clinical response at the time of study completion will be provided with open-label infliximab for treatment of their conditions and additional safety data will be collected.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Experiencing Any Adverse Event

  throughout entire study (61 +/- 28.9 weeks on average)

• Number of Subjects Experiencing Serious Adverse Event

  Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.

  throughout entire study (61 +/- 28.9 weeks on average)

• Number of Subjects Experiencing Any Infection

  throughout entire study (61 +/- 28.9 weeks on average)

Study Arms (1)

Open Label Infliximab + Methotrexate

EXPERIMENTAL

Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)

Biological: Infliximab + methotrexate (MTX)

Interventions

Infliximab + methotrexate (MTX) BIOLOGICAL

Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)

Also known as: Remicade, SCH 215596

Open Label Infliximab + Methotrexate

Eligibility Criteria

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

You may qualify if:

• Patients received placebo in main double-blind study (P04280, NCT00202852)
• Patients received Infliximab-containing regimen showing clinical response at week 30 in main double-blind study (P04280)
• Diagnosis of rheumatoid arthritis (RA) according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed \>6 months prior to screening.
• Active disease at the time of screening and pre-infusion as defined by:
• \>=6 swollen joints
• \>=6 tender joints and
• of the following:
• morning stiffness \>=45 min
• erythrocyte sedimentation rate (ESR) \>=28 mm/h
• C-reactive protein (CRP) \>=20 mg/L
• Men and women, \>=18 to \<=75 years of age
• Men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, intrauterine device (IUD), barrier method with spermicide, or surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion.
• Must have been using oral or parenteral MTX for \>3 months with no break(s) in treatment of \>2 weeks total during this period. Patients must have been on a stable dose of \>=12.5 mg/wk (maximum 20 mg/wk) for at \>4 weeks prior to screening.
• Must be on a stable dose of folic acid prophylaxis for \>4 weeks prior to screening.
• Patients using oral corticosteroids, must have been on a stable dose of \<=10 mg/day for \>4 weeks prior to screening. If currently not using corticosteroids the patient must have not received corticosteroids for \>4 weeks prior to screening.

You may not qualify if:

• Pregnant women, nursing mothers, or a planned pregnancy within 1.5 years of enrollment.
• Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
• Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from infliximab, eg Lyme disease, or a rheumatic disease other than RA.
• Use of disease modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.)
• Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening.
• Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab)
• Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months.
• Treatment with any investigational drug within the previous 3 months.
• Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents.
• History of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions.
• History of infected joint prosthesis within previous 5 years.
• Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.
• Chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis.
• Active tuberculosis (TB). Also excluded are patients who have evidence of latent TB (positive purified protein derivative \[PPD\] skin test or a history of latent TB) without adequate therapy for TB initiated prior to first infusion of study drug. Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy, if they will not be treated with antitubercular therapy during the trial. Patients with a current close contact with an individual with active TB will also be excluded. Additionally, patients who have completed treatment for active TB within the previous 2 years are now explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies. Also excluded are patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc, within the previous 6 months.
• Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Kim J, Ryu H, Yoo DH, Park SH, Song GG, Park W, Cho CS, Song YW. A clinical trial and extension study of infliximab in Korean patients with active rheumatoid arthritis despite methotrexate treatment. J Korean Med Sci. 2013 Dec;28(12):1716-22. doi: 10.3346/jkms.2013.28.12.1716. Epub 2013 Nov 26.

  PMID: 24339699 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab; Methotrexate

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: August 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 13, 2017
• Results First Posted: July 21, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share