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

Arthritis, Rheumatoid Clinical Trial

Official title:

A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00634933
• Other study ID #: 3206K1-2203
• Secondary ID: B2051001
• Status: Terminated
• Phase: Phase 2
• First received: March 5, 2008
• Last updated: February 6, 2013
• Start date: March 2008
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01616706

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: October 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Any prior use of rituximab or other B cell depleting agents.

• Any significant health problem other than rheumatoid arthritis

• Clinically significant laboratory abnormalities

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• TRU-015
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).
• Methylprednisolone
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).
• Prednisone
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)
• TRU-015
IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).
• Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).
• Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).
• TRU-015
IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).
• Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).
• Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Liege
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	Kitchener	Ontario
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Sydney	Nova Scotia
Canada	Pfizer Investigational Site	Trois-Rivieres	Quebec
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	PARIS Cedex 14
France	Pfizer Investigational Site	Toulouse
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Vogelsang	Gommern
Germany	Pfizer Investigational Site	Wuerzburg
Germany	Pfizer Investigational Site	Wuerzburg
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Debrecen
Hungary	Pfizer Investigational Site	Nyiregyhaza
Mexico	Pfizer Investigational Site	Culiacan	Sinaloa/Mexico
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Mexicali	Baja California/Mexico
Mexico	Pfizer Investigational Site	Mexico City
Mexico	Pfizer Investigational Site	Morelia	Michoacan
Netherlands	Pfizer Investigational Site	Leiden
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Cluj-Napoca
Romania	Pfizer Investigational Site	Iasi
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Niska Banja
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clarksburg	West Virginia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Danville	Pennsylvania
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Flowood	Mississippi
United States	Pfizer Investigational Site	Grande Rapids	Michigan
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Mayfield Village	Ohio
United States	Pfizer Investigational Site	Minot	North Dakota
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Palm Harbor	Florida
United States	Pfizer Investigational Site	Paradise Valley	Arizona
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Santa Maria	California
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	State College	Pennsylvania
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Wexford	Pennsylvania
United States	Pfizer Investigational Site	Wilkes Barre	Pennsylvania
United States	Pfizer Investigational Site	Worcester	Massachusetts
United States	Pfizer Investigational Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Trubion Pharmaceuticals/Emergent BioSolutions Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Mexico,  Netherlands,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response	ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% 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 (HAQ-DI); and CRP.	Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response	ACR50 response: >=50% 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 (HAQ-DI); and CRP.	Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% 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 (HAQ-DI); and CRP.	Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Number of Tender Joints	The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Number of Swollen Joints	The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.	Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Duration of Morning Stiffness	Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Visual Analogue Scale for Pain (VAS-pain)	100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Physician Global Assessment (PGA) of Disease Activity	Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Patient Global Assessment (PtGA) of Disease Activity	Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	General Health Visual Analog Scale (VAS)	100 mm line (VAS) marked by participant. Participants were asked, "How do you feel concerning your arthritis?" Total possible score range, 0 mm = very well to 100 mm = extremely bad.	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI)	HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	Disease Activity Score Based on 28-joints Count (DAS28)	DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.	Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No
Secondary	36-Item Short-Form Health Survey (SF-36)	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline, Week 12, 24, 36, 52	No
Secondary	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 12, 24, 36, 52	No
Secondary	Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.	Baseline, Week 12, 24, 36, 52	No
Secondary	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score	FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).	Baseline, Week 12, 24, 36, 52	No
Secondary	Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score	WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.	Baseline, Week 12, 24, 36, 52	No
Secondary	Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28	The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.	Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	No

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