Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate

Procter & Gamble (P&G)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo dose; Drug: PG-760564

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369928

2006012

Details and patient eligibility

About

This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Full description

The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.

The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.

After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.

The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Enrollment: 254 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
• Disease duration of at least 6 months
• Must be treated with Methotrexate for at least 24 weeks
• At least 6 swollen joints and 6 tender joints
• Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
• Women of childbearing age and all males must use acceptable method of birth control

Exclusion criteria

• Tuberculosis
• Malignancies
• Abnormal electrocardiograms as described in the protocol
• Current infection or recurrent infections or immunodeficiency
• Liver diseases and abnormalities in liver function tests as described in the protocol
• Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;
• History of demyelization diseases
• Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

254 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo, oral dose, BID

Treatment:

Drug: Placebo dose

25 mg PG-760564

Experimental group

Description:

25 mg BID, of oral PG-760564

Treatment:

Drug: PG-760564

Drug: PG-760564

100 mg PG-760564

Experimental group

Description:

100 mg BID, of oral PG-760564

Treatment:

Drug: PG-760564

Drug: PG-760564