Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis

NCT00634933 | Terminated Phase 2 Results

• 2 other identifiers: 3206K1-2203B2051001
• Study Type: interventional
• Target: 222
• Locations: 10 countries
• Sites: 65

Brief Summary

This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.

Conditions

Arthritis, Rheumatoid

Keywords

active; rheumatoid; arthritis; anti CD20

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24

  ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and C-Reactive Protein (CRP).

  Week 24

Secondary Outcomes (18)

• Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

  Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

• Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

  Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52

• Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

  Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

• Number of Tender Joints

  Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

• Number of Swollen Joints

  Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Study Arms (3)

Arm 1

EXPERIMENTAL

Consists of Arms 1a and 1b

Drug: TRU-015; Drug: Methylprednisolone; Drug: Prednisone

Arm 2

EXPERIMENTAL

Consists of Arms 2a and 2b

Drug: TRU-015; Drug: Methylprednisolone; Drug: Prednisone

Arm 3

PLACEBO COMPARATOR

Consists of Arms 3a and 3b.

Drug: TRU-015; Drug: Methylprednisolone; Drug: Prednisone

Interventions

TRU-015 DRUG

IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).

Arm 1

Methylprednisolone DRUG

IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).

Arm 1

Prednisone DRUG

Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)

Arm 1

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.

You may not qualify if:

• Any prior use of rituximab or other B cell depleting agents.
• Any significant health problem other than rheumatoid arthritis
• Clinically significant laboratory abnormalities

Sponsors & Collaborators

• Pfizer: lead
• Trubion Pharmaceuticals/Emergent BioSolutions Inc.: collaborator

Study Sites (65)

Pfizer Investigational Site

Birmingham, Alabama, 35294-7201, United States

Location

Pfizer Investigational Site

Paradise Valley, Arizona, 85253, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Santa Maria, California, 93454-6945, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Daytona Beach, Florida, 32117, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34474, United States

Location

Pfizer Investigational Site

Palm Harbor, Florida, 34684, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62704, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01605, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01608, United States

Location

Pfizer Investigational Site

Grande Rapids, Michigan, 49546, United States

Location

Pfizer Investigational Site

Flowood, Mississippi, 39232, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Syracuse, New York, 13210, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28210, United States

Location

Pfizer Investigational Site

Minot, North Dakota, 58701, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45245, United States

Location

Pfizer Investigational Site

Mayfield Village, Ohio, 44143, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Pfizer Investigational Site

Danville, Pennsylvania, 17822, United States

Location

Pfizer Investigational Site

State College, Pennsylvania, 16801, United States

Location

Pfizer Investigational Site

Wexford, Pennsylvania, 15090, United States

Location

Pfizer Investigational Site

Wilkes-Barre, Pennsylvania, 18711-3762, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78232, United States

Location

Pfizer Investigational Site

Clarksburg, West Virginia, 26301, United States

Location

Pfizer Investigational Site

Brussels, 1200, Belgium

Location

Pfizer Investigational Site

Liège, 4000, Belgium

Location

Pfizer Investigational Site

Kelowna, British Columbia, V1W 4V5, Canada

Location

Pfizer Investigational Site

Kelowna, British Columbia, V1Y 3G8, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Pfizer Investigational Site

Sydney, Nova Scotia, B1S 3N1, Canada

Location

Pfizer Investigational Site

Kitchener, Ontario, N2M 5N6, Canada

Location

Pfizer Investigational Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Pfizer Investigational Site

Montpellier, France, 34059, France

Location

Pfizer Investigational Site

Paris, 75674, France

Location

Pfizer Investigational Site

Toulouse, 31059, France

Location

Pfizer Investigational Site

Vogelsang, Gommern, 39245, Germany

Location

Pfizer Investigational Site

Cologne, 50924, Germany

Location

Pfizer Investigational Site

Essen, 45239, Germany

Location

Pfizer Investigational Site

Würzburg, 97070, Germany

Location

Pfizer Investigational Site

Würzburg, 97080, Germany

Location

Pfizer Investigational Site

Budapest, 1023, Hungary

Location

Pfizer Investigational Site

Debrecen, 4043, Hungary

Location

Pfizer Investigational Site

Nyíregyháza, 4400, Hungary

Location

Pfizer Investigational Site

Mexicali, Baja California/Mexico, 21100, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44100, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44158, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44650, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44690, Mexico

Location

Pfizer Investigational Site

Morelia, Michoacán, 58070, Mexico

Location

Pfizer Investigational Site

Culiacán, Sinaloa/Mexico, 80020, Mexico

Location

Pfizer Investigational Site

Mexico City, 06700, Mexico

Location

Pfizer Investigational Site

Leiden, 2333 ZA, Netherlands

Location

Pfizer Investigational Site

Iași, Iaşi, 700081, Romania

Location

Pfizer Investigational Site

Bucharest, Romania, 020983, Romania

Location

Pfizer Investigational Site

Cluj-Napoca, Romania, 400006, Romania

Location

Pfizer Investigational Site

Bucharest, 011172, Romania

Location

Pfizer Investigational Site

Bucharest, 020983, Romania

Location

Pfizer Investigational Site

Belgrade, 11000, Serbia

Location

Pfizer Investigational Site

Niška Banja, 18250, Serbia

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity; Arthritis

Interventions

TRU-015 protein; Methylprednisolone; Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Limitations and Caveats

As the results of the primary analysis did not meet the predefined efficacy criteria, the development of TRU-015 was discontinued.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: October 1, 2012
• Last Updated: March 11, 2013
• Results First Posted: March 11, 2013

Record last verified: 2013-02

Locations

NL (1); FR (3); DE (5); SE (2); HU (3); CA (7); ME (8); US (29); BE (2); RO (5)