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Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Canakinumab (investigational) (Drug); Placebo (Drug); Methotrexate (MTX) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigative site

Summary

This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)

Clinical Details

Official title: A 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50)

Secondary outcome:

Response to Intravenous (IV) Canakinumab and Oral Methotrexate (MTX) Therapy (ACR20, 70, 90) Compared to MTX Alone

Percentage of Participants Achieving a Good European League Against Rheumatism (EULAR) Response (Based on the Disease Activity Score (DAS28)) at 26 Weeks

The Number of Participants in Clinical Remission Based on Disease Activity Score (DAS)28 and Simplified Disease Activity Index (SDAI)

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female patients of 18 to 75 years of age (inclusive)

- Recent definite diagnosis of rheumatoid arthritis (RA) (<3 years since diagnosis),

classified by American Rheumatism Association 1987 revised criteria.

- Candidate for methotrexate (MTX) or biologic due to erosive arthritis, with no

contraindications to such therapy, including:

- Negative tuberculin skin test reaction

- Normal chest X-ray (within the last year) prior to possibility of receiving MTX (r/o

lung fibrosis).

- Active disease: at least 6 swollen and 6 painful tender joints of 28 joint count,

- Vital signs should be within the following ranges:

- 18-59 years of age: oral temperature between 35. 0-37. 5 °C systolic blood pressure,

90-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 90 beats per

minute

- 60-75 years of age: oral temperature between 35. 0-37. 5 °C systolic blood pressure,

100-160 mm Hg diastolic blood pressure, 50-100 mm Hg pulse rate, 50 - 100 beats per

minute

- Women of child-bearing potential willing to practice double-barrier contraception

during the study for at least 3 months following last study drug administration. Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion. Surgically sterilized women at least 6 months prior to screening. Male patients must be using a double-barrier local contraception and refrain from fathering a child in the 3 months following last study drug administration.

- Weight: at least 45 kg; body mass index (BMI) within the range of 18 to 34.

- Oral corticosteroids are permitted as long as patients are on a stable dose (up to 10

mg) for at least 4 weeks before study start. Exclusion Criteria:

- Unable to have Magnetic Resonance Imaging (MRI) of wrist.

- Patients with magnetizable metal parts/devices on and in the body that could

interfere with the MRI

- Patients with an unstable active medical condition that could impair evaluation of

study results.

- Previous treatment with biological therapy or MTX.

- Limited kidney function (creatinine clearance under 60 ml/min)

- Previous treatment with other disease-modifying anti-rheumatic drugs such as

sulfasalazine, hydroxychloroquine within 4 weeks of screening.

- Corticosteroids injections into joints within 4 weeks prior to screening.

- Participation in any clinical investigation within 4 weeks prior to study start or

longer if required by local regulations, and for any other limitation of participation based on local regulations.

- Blood donation or loss of > 400 mL within 8 weeks before study start, or longer if

required by local regulation.

- Significant illness within 2 weeks of study start.

- Past personal or family medical history of clinically significant ECG abnormalities

or cardiac issues.

- History of:

- fainting, orthostatic hypotension, sinus arrhythmia asthma and chronic

obstructive pulmonary disease, clinically significant drug allergy or urticaria, eczematous dermatitis, and/or known hypersensitivity to the study drug or drugs similar to the study drug.

- disease of the blood building system, serious or active infections, gastric

ulcers.

- surgical or medical condition which might significantly alter the absorption,

distribution, metabolism or excretion of drugs or which may jeopardize the patient in case of participation in the study.

- immunodeficiency diseases, including a positive Human Immunodeficiency Virus

(HIV) (ELISA and Western blot) test result.

- positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

- drug or alcohol abuse within the 12 months prior to dosing or evidence of such

abuse.

Locations and Contacts

Novartis Investigative site, Brussels, Belgium

Novartis investigative site, Nuernberg, Germany

Novartis investigative site, Milan, Italy

Novartis Investigative site, Arnhem, Netherlands

Novartis investigative site, Barcelona, Spain

Rheumatology Associates of Northern Alabama (Dr. William Shergy), Huntsville, Alabama 35801, United States

Clinic for Rheumatic Diseases (Dr. Richard Jones, III), Tuscaloosa, Alabama 35406, United States

Arizona Arthritis and Rheumatology Research (Dr. Paul Caldron), Paradise Valley, Arizona 85253, United States

Jacksonville Center for Clinical Research (Dr. Steven Mathews), Jacksonville, Florida 32216, United States

Center for Arthritis and Rheumatic Diseases (Dr. Michael Weitz), South Miami, Florida 33143, United States

West Broward Rheumatology Associates, Incorporated (Dr. Elias Halpert), Tamarac, Florida 33321, United States

Rockford Orthopedic Associates (Dr. Richard Olson), Rockford, Illinois 61107, United States

Mercy Arthritis and Osteoporosis Center (Dr. Alan Braun), Urbandale, Iowa 50322, United States

Clayton Medical Research (Dr. Iri Don), Richmond Heights, Missouri 63117, United States

Westroads Medical Group (Dr. William Palmer), Omaha, Nebraska 68114, United States

Arthritis Center of Reno (Dr. Malin Prupas), Reno, Nevada 89502, United States

Oklahoma Center for Arthritis therapy and Research (Dr. James McKay), Tulsa, Oklahoma 74104, United States

MetaClin Research, Incorporated (Dr. Paul Pickrell), Austin, Texas 78704, United States

John M. Joseph, MD (Dr. John Joseph), Carlton, Texas 75007, United States

Southwest Rheumatology, P.A. (Dr. Atul Singhal), Mesquite, Texas 75150, United States

Arthritis Clinic of Northern Virginia (Dr. Philip Kempf), Arlington, Virginia 22205, United States

Arthritis Northwest Rheumatology, PLLC (Dr. Jeffrey Butler), Spokane, Washington 99204, United States

Additional Information

Starting date: March 2007
Last updated: July 24, 2012

Page last updated: August 23, 2015

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