Back to results

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

Primary Purpose

Arthritis, Rheumatoid

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

TRU-015

Methylprednisolone

Prednisone

TRU-015

Methylprednisolone

Prednisone

TRU-015

Methylprednisolone

Prednisone

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring active, rheumatoid, arthritis, anti CD20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Consists of Arms 1a and 1b

Consists of Arms 2a and 2b

Consists of Arms 3a and 3b.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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.

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.

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.

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).

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.

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.

Patient Global Assessment (PtGA) of Disease Activity

Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.

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.

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.

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.

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).

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.

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.

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).

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.

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.

Full Information

NCT ID

NCT00634933

First Posted

March 5, 2008

Last Updated

February 6, 2013

Sponsor

Pfizer

Collaborators

Trubion Pharmaceuticals/Emergent BioSolutions Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00634933

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.

Study Start Date

March 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

Trubion Pharmaceuticals/Emergent BioSolutions Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

active, rheumatoid, arthritis, anti CD20

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Consists of Arms 1a and 1b

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Consists of Arms 2a and 2b

Arm Title

Arm 3

Arm Type

Placebo Comparator

Arm Description

Consists of Arms 3a and 3b.

Intervention Type

Drug

Intervention Name(s)

TRU-015

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

TRU-015

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

TRU-015

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Tender Joints

Description

Time Frame

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

Title

Number of Swollen Joints

Description

Time Frame

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

Title

Duration of Morning Stiffness

Description

Time Frame

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

Title

Visual Analogue Scale for Pain (VAS-pain)

Description

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.

Time Frame

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

Title

Physician Global Assessment (PGA) of Disease Activity

Description

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.

Time Frame

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

Title

Patient Global Assessment (PtGA) of Disease Activity

Description

Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.

Time Frame

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

Title

General Health Visual Analog Scale (VAS)

Description

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.

Time Frame

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

Title

Health Assessment Questionnaire Disability Index (HAQ-DI)

Description

Time Frame

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

Title

Disease Activity Score Based on 28-joints Count (DAS28)

Description

Time Frame

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

Title

36-Item Short-Form Health Survey (SF-36)

Description

Time Frame

Baseline, Week 12, 24, 36, 52

Title

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score

Description

Time Frame

Baseline, Week 12, 24, 36, 52

Title

Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)

Description

Time Frame

Baseline, Week 12, 24, 36, 52

Title

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score

Description

Time Frame

Baseline, Week 12, 24, 36, 52

Title

Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score

Description

Time Frame

Baseline, Week 12, 24, 36, 52

Title

Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-7201

Country

United States

Facility Name

Pfizer Investigational Site

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454-6945

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Pfizer Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Pfizer Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Pfizer Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Pfizer Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01608

Country

United States

Facility Name

Pfizer Investigational Site

City

Grande Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

Pfizer Investigational Site

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Pfizer Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Pfizer Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Pfizer Investigational Site

City

Mayfield Village

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Pfizer Investigational Site

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

Pfizer Investigational Site

City

State College

State/Province

Pennsylvania

ZIP/Postal Code

16801

Country

United States

Facility Name

Pfizer Investigational Site

City

Wexford

State/Province

Pennsylvania

ZIP/Postal Code

15090

Country

United States

Facility Name

Pfizer Investigational Site

City

Wilkes Barre

State/Province

Pennsylvania

ZIP/Postal Code

18711-3762

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78232

Country

United States

Facility Name

Pfizer Investigational Site

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Pfizer Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1W 4V5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 3G8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Sydney

State/Province

Nova Scotia

ZIP/Postal Code

B1S 3N1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montpellier

ZIP/Postal Code

34059

Country

France

Facility Name

Pfizer Investigational Site

City

PARIS Cedex 14

ZIP/Postal Code

75674

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Pfizer Investigational Site

City

Vogelsang

State/Province

Gommern

ZIP/Postal Code

39245

Country

Germany

Facility Name

Pfizer Investigational Site

City

Essen

ZIP/Postal Code

45239

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koeln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wuerzburg

ZIP/Postal Code

97070

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Mexicali

State/Province

Baja California/Mexico

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44158

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44690

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58070

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Culiacan

State/Province

Sinaloa/Mexico

ZIP/Postal Code

80020

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

020983

Country

Romania

Facility Name

Pfizer Investigational Site

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Pfizer Investigational Site

City

Iasi

ZIP/Postal Code

700081

Country

Romania

Facility Name

Pfizer Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Pfizer Investigational Site

City

Niska Banja

ZIP/Postal Code

18250

Country

Serbia

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3206K1-2203&StudyName=Study%20Evaluating%202%20Dosing%20Regimens%20Of%20TRU-015%20In%20Rheumatoid%20Arthritis

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial