An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra

• Register: EUCTR
• Last refreshed on: 3 July 2012
• Main ID: EUCTR2007-001625-10-AT
• Date of registration: 04/06/2008
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals France
• Public title: An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra
• Scientific title: An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra
• Date of first enrolment: 09/10/2008
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001625-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1- 18 years of age or older at time of consent.

2- Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.

3- Active Rheumatoid Arthritis: evidence of clinical signs of joint inflammation / swelling at screening and randomization.

4- Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray (hands or feet) at randomization based on X-ray taken at the screening visit. Subjects with no confirmed erosion at the randomization visit are to be withdrawn.

5- Plasma C-reactive protein level of at least 8.0 mg/L or Erythrocyte Sedimentation Rate of at least 28mm/h in sample taken at the screening visit.

6- Currently receiving optimized* treatment with MTX but with active disease as defined by a DAS28 score of >3.20 and <=5.10 at both the screening and randomization visits. The erythrocyte sedimentation rate (ESR) value at the screening visit will be used for the DAS 28 calculation at the randomization visit. Have received MTX orally, intramuscularly or SC for at least 4 months before screening with at least 2 months at the highest tolerated dose (not less than 12.5mg/week).

7- Have received MTX at stable dose for 28 days prior to the screening visit.

8- In the opinion of the investigator, suitable for continued treatment with MTX at a dose of 12.5 mg/week or greater, but no more than 25 mg/week.

9- Functional status Class I, II or III as defined by ACR Revised Criteria.

10- Onset of disease after 16 years of age.

11- In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits.

12- Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.

13- Able and willing to self-inject study drug or have a designee who can do so.

14- Able and willing to take oral medication.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Previous treatment with ETN, infliximab, adalimumab, other TNF-a inhibitors, anakinra or other biological agents.

Receipt of any DMARD, other than MTX, within 28 days before screening.

Unable to tolerate MTX at a minimum dose of 12.5 mg/week orally, intramuscularly or SC.

Known significant (in the opinion of the investigator) concurrent medical disease including:·
Uncompensated congestive heart failure, or class III or IV heart failure defined by the New York Heart Association classification.
History of or current pancytopenia or aplastic anemia.
Diagnosis of multiple sclerosis or other central or peripheral nervous system demyelinating diseases.
Current malignancy or an individual history of cancer (other than resected basal cell carcinoma of the skin) within five years of the screening visit.
Active infection including known human immunodeficiency virus (HIV) infection and tuberculosis (TB). (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy)
Sepsis, or at risk of sepsis.
Subjects with signs of immunodeficiency.
Other current autoimmune connective tissue diseases such as diagnosis of systemic lupus erythematosus, scleroderma, or polymyositis.
Significant renal disease in the investigator’s opinion.
Abnormal hematology or chemistry profiles:
· white blood cell (WBC) count =<3.5 x 109/L
· Hemoglobin level =<85 g/L or 5.3 mmol/L
· Hematocrit =<27%.
· Platelet count =<125 x 109/L
· Serum creatinine level =>175 µmol/L
· Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level =>2 times the laboratory’s upper limit of normal
· Clinically significant abnormal screening laboratory values in the investigator’s opinion (based on country-specific standard of care)

Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.

Use of any investigational treatment or device within 3 months (or 5 half lives of the treatment, whichever is longer) of the screening visit.

Concomitant oral corticosteroid >10 mg/day of prednisone or its equivalent at the point of screening (corticosteroid dose must be stable for at least four weeks prior to screening).

Intra-articular, intravenous, intramuscular or subcutaneous (SC) corticosteroid injection within 28 days of the screening visit.

Active alcoholism and/or substance abuse within one year of the screening visit.

Conditions requiring initiation of new drug therapy concurrent with entry into this study.

Receipt of any live viral or bacterial vaccines (attenuated vaccines) within 28 days prior to screening


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

RHEUMATOID ARTHRITIS
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Intervention(s)

Trade Name: Enbrel 50 mg
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: To compare the effects of ETN + MTX and usual treatment on clinical outcomes.
To compare the effects of ETN + MTX and usual treatment on health-related quality of life and dimensions of impact of disease on subjects over 52 weeks.
To evaluate the safety of the treatment regimen over 52 weeks.

Main Objective: To evaluate the impact of ETN + MTX in comparison with usual treatment on radiographic disease progression at 52 weeks in subjects with moderate RA who failed treatment with MTX.

Primary end point(s): The primary endpoint for this study is the change from randomization in modified TSS at 52 weeks.

Secondary ID(s)

0881X1-4437

2007-001625-10-HU