A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

• Conditions: Treatment of patients with moderate to severe rheumatoid arthritis (RA); MedDRA version: 14.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-000436-28-BG
• Lead Sponsor: Zalicus, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-06
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

1.Prior to Screening have voluntarily signed the informed consent form.

2.At Screening be at least 18 years of age.

3.At Screening meet the ACR / EULAR criteria for classification of RA(please refer to Section 5.13.2 and/or Appendix B [Section 12.2] for additional details)which include:
oJoint involvement
oSerology
oAcute-phase reactants
oDuration of symptoms

4. At Screening have moderate to severe RA, defined as involving a minimum (=6 total swollen and =6 total tender) of the 28 joints assessed.

5. At Screening have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score =4.5. Retesting of the CRP and recalculation of DAS28-CRP (due to CRP <0.6 mg/dL) is allowed one time.

6. Have been on DMARD therapy for at least 90 days, have been on stable DMARD dose without dosage adjustment or modification for 6 weeks, and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy). Stable DMARD therapy may include a combination of DMARD agents (methotrexate and azsulfadine or methotrexate and hydroxychloroquine as examples).

7. At Screening, female patients of childbearing potential (18 to 55 years of age, inclusive) must have negative urinary BhCG test.

8. Female patients of childbearing potential (18 to 55 years of age, inclusive) must use acceptable methods of birth control (including, but not limited to, IUD, oral or injectable contraceptives, or barrier methods) while in the study.

9. 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 the trial and will continue on the same dose for the duration of the trial: statins, diuretics, thyroid hormone, hypoglycemic medications, and cardiovascular medications.

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Female patient is pregnant or lactating or of child bearing potential not using acceptable methods of birth control including,but not limited to,IUD,oral or injectable contraceptives,barrier methods or abstinence
2.Patients who do not respond to therapies that include a dose < 10mg prednisone and either a DMARD combination,DMARDbiologic combination or biologics alone
3.Active cardiovascular disease,unless well controlled by appropriate treatment for a minimum of 3months prior to screening
4.Currently taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325mg
5.Taking oral steroids at a daily prednisone dose,or the equivalent,of >10mg/day within the past 2weeks
6.Intraarticular,intramuscular,or intravenous glucocorticoids must not have been given at least 6weeks prior to entering the study or be anticipated to be given at any time during the study
7.The need to continue the use of one or multiple NSAIDs at the same time,or the use of acetaminophen on a chronic basis. Ataminophen/paracetamol will be permitted episodically for pain during the trial,not exceeding 1.5gper day for any 3days in any 7day interval.There are no exclusions during the 30day followup period
8.All opiate use is prohibited.Such agents include oxycodone, hydrocodone,codeine,morphine sulfate,Demerol(meperidine/pethidine),Dilaudid(hydromorphone),combination products including Percocet(oxycodone and acetaminophen),Hydrocet(dihydrocodeine andacetaminophen),Tylenol(acetaminophen or paracetamol) with codeine,Vicodin(hydrocodone and acetaminophen),Lorcet(hydrocodone and acetaminophen),Lortabs(hydrocodone and acetaminophen)and extended-release formulations
9.Use of any other medications or herbs or non pharmacological treatments eg acupuncutre used for the treatment of pain is prohibited
10.Excluded medications include
Drugs known to interact with dipyridamole(egadenosine, cholinesterase inhibitors,theophylline,caffeine and other xanthine derivatives)or with prednisolone(eganticoagulants,antifungals and HIV protease inhibitors)Systemic anticoagulants,including dipyridamole,Coumadin(warfarin),clopidogrel,ticlopidine and aspirin exceeding 325mg/day(whether or not taken for cardiovascular prophylaxis)
All Systemic antifungal agents, including but not limited to the polyene macrolides(amphotericin B),the azoles(ketoconazole,miconazole,itraconazole and fluconazole) and the allylamines(terbinafine)
All antiHIV drugs belonging to the following classes: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
11.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 30days of study initiation
12.Tuberculosis
At screening patients with a history of or currently active tuberculosis as per specific country guidelines are excluded
Patients with a positive Chest XRay eg apical thickening compatible with TB exposure/latency are excluded
Patients who have a positive PPD test, in association with compatible signs and symptoms and/or a positive or indeterminate QFT are excluded
Note:A patient with a previous positive PPD test is at risk for develo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified