Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)

• Register: EUCTR
• Last refreshed on: 3 September 2012
• Main ID: EUCTR2007-006657-63-FI
• Date of registration: 27/01/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom
• Public title: Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)
• Scientific title: Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA
• Date of first enrolment: 08/05/2009
• Target sample size: 72
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006657-63
• 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: yes Other trial design description: Patients who fail during the trial will enter into an open-label phase If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Denmark, Finland, Hungary, Iceland, Norway, Sweden

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion Criteria for the Open-label Period (Period 1):
Subject must meet all of the following conditions in order to be enrolled in the study:
1. Men and women have a diagnosis of RA based on the ACR Revised Criteria for RA.
2. Subject has a current DAS28 =3.2.
3. Subject is currently receiving treatment with sc ETN, either 25 mg BW or 50 mg QW, for a minimum of 14 months at baseline
4. Subject is currently receiving oral, sc or im MTX, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.


Inclusion Criteria for the Double-Blind Randomized Period (Period 2)
1. Subject has completed open-label period 1 and has had DAS28 = 3.2 at all visits during period 1 and at randomization.


Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Exclusion Criteria for the Open-Label Period (Period 1)
1· Subject has earlier had an attempt of discontinuing ETN for reasons of remission or LDA state.
2. Subject has received any disease-modifying anti-rheumatic drug (DMARD), other than MTX, a dose of prednisone (or equivalent) >7.5 mg/day or has received ia, iv, im, or sc corticosteroid within one month before baseline.

Exclusion Criteria for the Double-Blind Randomized Period 2

1. Subject has used prohibited concomitant medication in period 1 or has not attended all visits in Period 1.

For additional criteria, see protocol


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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: Enbrel 25 mg powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Enbrel 50 mg powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Proportion of subjects who are non-failures at Week 48

Main Objective: To compare the effect on disease activity of the combination of ETN 50 mg QW plus methotrexate (MTX) to placebo plus MTX over 48 weeks in RA subjects who at study start are in remission or LDA state with combination therapy with ETN 50mg weekly plus MTX

Secondary Objective: 1. To compare the effect on disease activity of the combination of ETN 25 mg QW plus MTX to

a. combination of ETN 50 mg QW plus MTX
b. placebo plus MTX

over 48 weeks in RA subjects who at study start are in remission or LDA state with combination therapy with ETN 50mg weekly plus MTX.

2. To compare the change in modified Total Sharp Score (mTSS) over 48 weeks among the treatment groups.

3. To compare the change in MRI findings over 12 weeks among the treatment groups.

Primary end point(s): Proportion of subjects who are non-failures at Week 48. These subjects are still in Period 2 at study end, which means they have not fulfilled predefined failure criteria during the study.

Secondary Outcome(s)

Secondary end point(s): In the three treatment arms:
1. Time from randomization to failure, according to predefined criteria.
2. Proportion of subjects in remission or LDA state at each visit.
3. Proportion of time subjects are in remission or LDA state
4. Change in DAS28 at each visit.
5. Change in tender and swollen joint counts at each visit.
6. Change in physician global assessments, subject global assessments, patient global health VAS, patient pain VAS and morning stiffness at each visit.
7. Changes in ESR and CRP at each visit.
8. Change in mTSS at week 48.
9. Change in MRI findings at week 12.
10. Correlation between clinical assessment, serum biomarkers, MRI (at randomization and week 12) and X-ray findings at randomization and whether individuals have had treatment failure or not.

Timepoint(s) of evaluation of this end point: • Time from randomization to failure.
• Proportion of subjects in remission or LDA state at each visit.
• Proportion of time subjects are in remission or LDA state
• Change in DAS28 at each visit.
• Change in tender and swollen joints at each visit.
• Change in physician global assessments, subject global assessments, patient general health VAS, patient pain VAS and morning stiffness at each visit.
• Changes in ESR and CRP at each visit.
• Change in mTSS at week 48.
• Change in MRI findings at week 12.
• Correlation between clinical assessment, serum biomarkers, MRI and X-ray findings at randomization and whether individuals have had treatment failure or not.

Secondary ID(s)

0881K1-4500-EU (B1801016)

Source(s) of Monetary Support

Pfizer Ltd