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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: 14 January 2013
Main ID:  EUCTR2011-002392-41-BG
Date of registration: 07/02/2012
Prospective Registration: Yes
Primary sponsor: Zalicus, Inc.
Public title: A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.
Scientific title: A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
Date of first enrolment: 09/04/2012
Target sample size: 200
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002392-41
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: yes Placebo: no Other: no Number of treatment arms in the trial: 3  
Phase: 
Countries of recruitment
Argentina Brazil Bulgaria Canada Chile Hungary Mexico Peru
Poland Russian Federation Serbia Ukraine United States
Contacts
Name: Clinical Trial Information    
Address:  1000 Continental Drive PA 19406 King of Prussia United States
Telephone: +001 610 9642012
Email: meera.jessani@wwctrials.com
Affiliation:  Worldwide Clinical Trials
Name: Clinical Trial Information    
Address:  1000 Continental Drive PA 19406 King of Prussia United States
Telephone: +001 610 9642012
Email: meera.jessani@wwctrials.com
Affiliation:  Worldwide Clinical Trials
Key inclusion & exclusion criteria
Inclusion criteria:
1. Prior to Screening, have voluntarily signed the Informed Consent Form. Completing patients from Protocol Z102-008 will sign informed consent for Protocol Z102-009 prior to their termination visit in Protocol Z102-008.
2. Have completed all 12 weeks of Protocol Z102-008 or discontinued after participating in at least 6 weeks of the randomized withdrawal portion of Z102-008 for acceptable reasons (i.e., for reasons other than Adverse Event (AE), protocol violation, or non-compliance). If Protocol Z102-008 participation terminated early, the full 12-week period (inclusive of study participation period) must elapse before participants in Z102-008 may be considered for participation in the 52-week extension study (Z102-009).
3. Have met all inclusion/exclusion criteria for enrollment into Protocol Z102-008.
4. Have been on DMARD therapy for at least 90 days and have been on a stable DMARD dose without dosage adjustment or modification for 6 weeks prior to enrollment into Protocol Z102-008, and be able to maintain the same dose of conventional DMARD therapy during Protocol Z102-009 participation (with or without glucocorticoid therapy); stable DMARD therapy may include a combination of DMARD agents (methotrexate and azulfidine or methotrexate and hydroxychloroquine as examples).
5. At Screening, female patients of childbearing potential (18 to 55 years of age, inclusive) must have negative urinary human chorionic gonadotropin (hCG) tests.
6. Female patients of childbearing potential (18 to 55 years of age, inclusive) must use acceptable methods of birth control (including, but not limited to, intrauterine device [IUD], oral or injectable contraceptives, barrier methods, or abstinence) for the duration of Protocol Z102-009.
7. If currently taking the following medications, she/he has been on a stable dose of the same drug for at least 3 months prior to entering into Protocol Z102-008, continued on the same dose during Protocol Z102-008, and should be able to continue on the same dose for the duration of Protocol Z102-009: statins, diuretics, thyroid hormone, hypoglycemic medications, and cardiovascular medications.
8. Have no general or specific changes in his/her condition unacceptable for further treatment in the judgment of the investigator.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion criteria:
1. Did not complete 6 weeks of the double-blind section of Protocol Z102-008, or was discontinued from Protocol Z102-008 for reasons of an AE, protocol violation, or non-compliance.
2. Female patient who is pregnant or lactating or of childbearing potential not using acceptable methods of birth control (including, but not limited to, IUD, oral or injectable contraceptives, barrier methods, or abstinence).
3. Patients who do not respond to therapies that include a dose less than 10 mg prednisone and either a DMARD combination, DMARD/biologic combination, or biologics alone.
4. Active cardiovascular disease, unless well controlled by appropriate treatment, for a minimum of 3 months prior to screening for enrollment into Protocol Z102-008.
5. Currently taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg.
6. Taking oral steroids at a daily prednisone dose, or the equivalent, of >10 mg/day within the past 2 weeks.
7. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering study Protocol Z102-008 or Protocol Z102-009, at any time during the study, or be anticipated to be given at any time during the study.
8. The need to continue the use of one or multiple NSAIDs at the same time, or use acetaminophen on a chronic basis. Acetaminophen/paracetamol is permitted episodically for pain during the titration and stable dose treatment period for Protocol Z102-009, not exceeding 1.5 g/day for any 3 days in any 7-day interval. There are no exclusions during the 30-day follow-up period.
9. All opiate use is prohibited. Such agents include oxycodone, hydrocodone, codeine, morphine sulfate, Demerol (meperidine/pethidine), Dilaudid (hydromorphone), tramadol, combination products including Percocet (oxycodone and acetaminophen), Hydrocet (dihydrocodeine and acetaminophen), Tylenol (acetaminophen or paracetamol) with codeine, Vicodin (hydrocodone and acetaminophen), Lorcet (hydrocodone and acetaminophen), Lortabs (hydrocodone and acetaminophen) extended-release formulations.
10. Use of any other medications or herbs or non-pharmacological treatments (e.g., acupuncture) used for the treatment of pain is prohibited.
11. Excluded medications include systemic anticoagulants, including dipyridamole, Coumadin (warfarin), clopidogrel, ticlopidine, and aspirin exceeding 325 mg/day (whether or not taken for cardiovascular prophylaxis). All systemic antifungal agents are excluded, including (but not limited to) the polyene macrolides (amphotericin B), the azoles (ketoconazole, miconazole, itraconazole, and fluconazole), and the allylamines (terbinafine). All anti-HIV drugs belonging to the following classes are prohibited: members of the nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside/nucleotide reverse transcriptase inhibitors, protease inhibitors, fusion and entry inhibitors, and integrin inhibitors. These agents include (but are not limited to) abacavir, zidovudine, didanosine, tenofovir, and efavirenz.
12. Has, or has had any active severe infections, such as osteomyelitis, sepsis, active infectious hepatitis, endocarditis, systemic fungal infection, or recent invasive surgical procedures within 30 days of Protocol Z102-008 or Protocol Z102-009 initiation.
13. Known HIV, hepatitis B, or hepatitis C infection.
14. Has undergone administration of any investigational drug within 30 days of study Proto


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 10021428 - Immune system disorders
Intervention(s)

Product Name: Z102
Product Code: Z102
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisolone
CAS Number: 52438-85-4
Current Sponsor code: Prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.7-
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Current Sponsor code: Dipyridamole
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 360-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Dacortin ®
Product Name: Prednisone
Pharmaceutical Form: Capsule
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5.0-7.5
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To determine the safety of Z102 relative to standard glucocorticoid comparators (5.0 mg and 7.5 mg prednisone) over a 12-month period in patients with RA using the following assessment tools:
o Adverse events
o Vital signs
o Clinical laboratory and clinical chemistry evaluations
o Physical examination and body weight
Primary end point(s): To determine the safety of Z102 relative to standard glucocorticoid comparators (5.0mg and 7.5mg prednisone) over a 12 month period in patients with Rheumatoid Arthritis (RA).
Secondary Objective: To evaluate the efficacy of Z102 relative to standard glucocorticoid comparators (5.0 mg and 7.5 mg prednisone) over a 12-month period in patients with RA using the following assessment tools:
o Joint imaging and bone density using plain radiography and dual-energy X-ray absorptiometry (DXA)
o Disease Activity Score 28 (DAS28)- C-reactive protein (CRP) and individual components
o American College of Rheumatology (ACR) 20, ACR 50, and ACR 70
o Multidimensional Assessment of Fatigue (MAF)
o Time to failure
Timepoint(s) of evaluation of this end point: Baseline to month 12
Secondary Outcome(s)
Secondary end point(s): To evaluate the efficacy of Z102 relative to standard glucocorticoid comparators (5.0mg and 7.5mg prednisone) over a 12 month period in patients with Rheumatoid Arthritis (RA).
Timepoint(s) of evaluation of this end point: Baseline to month 12
Secondary ID(s)
2011-002392-41-HU
Z102-009
Source(s) of Monetary Support
Zalicus, Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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