A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2004-001490-26-GB
• Date of registration: 01/06/2005
• Prospective Registration: No
• Primary sponsor: CombinatoRx, Inc
• Public title: A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA
• Scientific title: A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA
• Date of first enrolment: 15/09/2004
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001490-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Estonia, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject must be at least 18 years of ages.
2. Have rheumatoid arthritis.
3. Have at least 5 swollen joints (max = 66) and 6 tender joints (max = 68).
4. Subject must have baseline C-reactive protein levels of at least 3.0 mg/L.
5. Subject must have been on DMARD therapy for at least 3 months and be on a stable dose of DMARD therapy for at least 28 days prior to enrollment. Subjects on stable methotrexate may receive it by the parenteral or oral route.
6. Subject must have voluntarily signed the informed consent.

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:
1. Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
2. Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
3. Subject is currently taking any anti-depressant or anti-seizure medications.
4. Subject has a history of seizure disorders.
5. Subject had a myocardial infarction within six months of enrollment.
6. Subject is currently taking more than 81 mg of aspirin daily.
7. Subject has a history of asthma, which is being treated with inhaled or other steroids.
8. Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
9. Subject has any active infections or recent surgical procedures within 30 days of study initiation.
10. Subject has uncontrolled diabetes mellitus as defined by a HbA1C value = 7.0%.
11. Subject knowingly has HIV or Hepatitis.
12. Subject is currently participating in a clinical research study, or has undergone administration of any investigational drug within 30 days of study initiation.
13. Subject has a history of hypersensitivity to tri-cyclic anti-depressants and/or dipyridamole.
14. Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.



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

Health Condition(s) or Problem(s) studied

RHEUMATOID ARTHRITIS

Intervention(s)

Trade Name: Asendis 50 mg
Asendis 100 mg
Persantin 100 mg
Product Name: N/A
Product Code: CRx-150
Pharmaceutical Form: Tablet
INN or Proposed INN: Amoxapine & dipyridamole
Current Sponsor code: CRx-150
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 or 100 and-100
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Evaluate the changes in inflammatory cytokines in subjects treated with CRx-150 plus DMARD therapy to placebo plus DMARD therapy.
Evaluate the efficacy of CRx-150 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices

Main Objective: Compare the response of CRx-150 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.

Primary end point(s): Compare the reduction in CRP levels between subjects treated with CRx-150 plus DMARD therapy and subjects treated with placebo plus DMARD therapy.

Secondary ID(s)

N/A

CRx-150-002-00