World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 January 2013
Main ID:  EUCTR2007-006150-25-HU
Date of registration: 01/04/2009
Prospective Registration: No
Primary sponsor: Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.
Public 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
Scientific 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 - TRU-015
Date of first enrolment: 04/07/2008
Target sample size: 216
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006150-25
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 6  
Phase: 
Countries of recruitment
Austria Belgium France Germany Hungary Mexico Netherlands Romania
Serbia
Contacts
Name: Clinical Trials.gov Call Center   
Address:  235 East 42nd Street, New York NY 10017 New York United States
Telephone: 0018007181021
Email: clinicaltrials.govcallcenter@pfizer.com
Affiliation:  Pfizer Inc.
Name: Clinical Trials.gov Call Center   
Address:  235 East 42nd Street, New York NY 10017 New York United States
Telephone: 0018007181021
Email: clinicaltrials.govcallcenter@pfizer.com
Affiliation:  Pfizer Inc.
Key inclusion & exclusion criteria
Inclusion criteria:
1. Age = 18 years at time of signing the ICF
2. Meets the American Rheumatism Association 1987 revised criteria for classification of RA.
3. ACR functional class I-III.
4. At screening, active RA consisting of = 5 swollen and = 5 tender joints (28-joint count: see Attachment 3) and one or both of the following CRP or ESR criteria:
a. Erythrocyte sedimentation rate (ESR)(Westergren) = 28 mm/hr
b. CRP = 15 mg /L
5. Must be seropositive: Defined as a documented history of one or both of the following RF or anti-CCP criteria.
If a documented history of one or both of the following RF or anti-CCP criteria is not available, RF and anti-CCP will be tested with screening labs:
a. Positive RF
b.Positive anti-CCP
6. Currently receiving MTX regimen of 7.5 to 25mg of MTX weekly for at least 12 weeks prior to study day 1.
The dose and route of administration of MTX must be stable for at least 4 weeks prior to study day 1.
7. Women of childbearing potential must have a negative urine pregnancy test at screening and baseline. Women of childbearing potential are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Women of non-childbearing potential are defined as either postmenopausal (history of amenorrhea for = 52 weeks) or who are surgically sterile, such as after hysterectomy, bilateral oophorectomy, or tubal ligation (procedure
performed = 1 year before screening). This information must be documented in the subject’s source documents.
8. Women of childbearing potential must agree and commit to the use of hormonal contraception, double-barrier contraception, or an intrauterine device throughout the entire study (defined as the signing of the ICF to the
completion of the Conclusion of Subject Participation). Double-barrier contraception is defined as the use of a diaphragm, condom, or cervical cap plus a spermicidal vaginal foam, cream, jelly, suppository, or sponge.
WOCBP who have a vasectomized partner are also eligible for participation. Vasectomized partners must have had their vasectomy more than 6 months before study day 1.
9. Men must agree and commit to use a medically acceptable form of contraception for the entire study (defined as the signing of the ICF to the completion of the Conclusion of Subject Participation) unless surgically sterile.
Medically acceptable forms of contraception include properly used barrier forms of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnant women, nursing mothers or women planning to become pregnant during the study. 2. Any cardiovascular, neurological, metabolic, immunological, infectious, hepatic, or renal condition that, in the opinion of the investigator, could be detrimental to subjects participating in this study, including any clinically important deviations from normal clinical laboratory values or important concurrent medical events. 3. Any active, severe infections
4. Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease 5. Subjects with active tuberculosis as per country specific guidelines or history of tuberculosis. The following applies to subjects in Germany only: History of tuberculosis or positive PPD skin test at screening. The following are PPD skin test guidelines: (a)The PPD skin test should be read between 48 & 72 hours after application (b)Only indurations should be taken into account when interpreting results. (c)No induration is considered a negative result. (d)Any result with an induration of >5 mm in diameter is considered positive. (e)If induration is =5 mm in diameter, a 2nd PPD skin test is to be performed on contralateral arm on the day of reading of first PPD skin test. If the induration of the 2nd PPD skin test is >5 mm in diameter, this is considered a positive result. (f)Prior BCG should not be taken into account when interpreting a PPD result. 6. Subjects with other objectively confirmed or suspected rheumatic diseases including but not limited to, Lyme disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious arthritis, reactive arthritis or overlap syndrome. 7. Cancer, or a history of cancer (other than adequately resected cutaneous basal cell & squamous cell carcinomas or in situ cervical cancer). 8. History of alcohol or drug abuse that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol. 9. Documented immunodeficiency disease including subjects with known human immuno deficiency virus (HIV) at time of screening. The following applies to subjects in Germany only: Known history of HIV, or positive HIV screening test, at the time of screening. 10 Subjects positive forhepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), or hepatitis C antibody (HepCAb) with confirmation by RIBA, or history of drug-induced liver injury, or documented liver cirrhosis or documented fibrosis at any time before the Baseline visit. 11. Any clinically significant laboratory abnormality, including: Hemoglobin <8.5 g/dL (SI units: <85 g/L); White blood cell (WBC) count <3.50 x 103/mm3 (SI units: <3.50 x 10 to the power of 9/L); Platelets <125,000/mm3 or = 1,000,000/mm3 (SI units: <125 x 10 to the power of 9/L or =1,000 x 10 to the power of 9/L); Aspartate minotransaminase (AST) or alanine aminotransaminase (ALT) >1.5 x upper limit of normal (ULN); Serum creatinine >2 mg/dL (SI units: >177 mol/L)
12. Clinically significant finding on chest radiograph.Chest x-ray must be performed during screening period unless radiograph was performed within the 24 weeks prior to Baseline. 13. For subjects who consent to the MRI sub-study:(a) Any permanent reactive metal implants contained in or on the body.(b) Contra indications to Gadolinium contrast agents including, but not limited to, glomerular filtration rate (GFR) <30 ml/min. 14. Lack of peripheral venous access. 15. Any prior use of rituxima


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

Product Name: TRU-015
Pharmaceutical Form: Lyophilisate for solution for infusion
Current Sponsor code: TRU-015
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Lyophilisate for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Decortin 5mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53032
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Solu-Medrone 125mg
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Methylprednisolone Sodium Succinate
CAS Number: 2375033
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: To evaluate the clinical efficacy of two dosing regimens of TRU-015 in active seropositive RA subjects compared with placebo at 24 weeks
Primary end point(s): The primary endpoint is the ACR 50 response rate at 24 weeks as assessed in Part A of this trial for the modified intent to treat (mITT) population.
Secondary Objective: To evaluate safety, patient reported outcomes, PK, PD, MRI, additional efficacy data up to 52 weeks, and asessment the effect of additional pre-dose oral corticosteroids at 12 weeks on 24-week efficacy.
Timepoint(s) of evaluation of this end point: The primary endpoint is the ACR 50 response rate at 24 weeks as assessed in Part A of this trial for the modified
intent to treat (mITT) population.
Secondary Outcome(s)
Secondary end point(s): ACR Secondary efficacy evaluations included the ACR20, ACR50 (except week 24), and ACR70 at all time points, a standardized joint assessment, duration of morning stiffness, pain VAS, Physician and Patient Global Assessments of disease activity, General Health VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score (DAS)28, Short Form-36 (SF-36), European Quality of Life (EuroQol) 5 Dimension Scale (EQ-5D), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Productivity and Disease Burden Questionnaire, and European League Against Rheumatism (EULAR) response as derived from DAS28.
Timepoint(s) of evaluation of this end point: To evaluate safety, patient reported outcomes, PK, PD, MRI, additional efficacy data up to 52 weeks, and asessment the effect of additional pre-dose oral corticosteroids at 12 weeks on 24-week efficacy.
Secondary ID(s)
2007-006150-25-FR
3206K1-2203-WW/B2051001
Source(s) of Monetary Support
Pfizer Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history