A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Keywords

• Rheumatoid Arthritis
• Moderate to severe

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 294 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Zalicus is the lead sponsor of 12 studies on the registry; none are open to participants now.

Study arms

• Active comparator
  Prednisolone

  Prednisolone 2.7 mg daily for 12 weeks

  Drug: Prednisolone

• Active comparator
  dipyridamole

  Dipyridamole 360 mg daily for 12 weeks

  Drug: dipyridamole

• Active comparator
  prednisone

  Prednisone 5 mg daily for 12 weeks

  Drug: Prednisone

• Experimental
  Z102 (2.7/360)

  Prednisolone 2.7 mg plus dipyridamole 360 mg daily for 12 weeks

  Drug: Z102

• Placebo comparator
  placebo

  Placebo daily for 12 weeks

  Other: placebo

Interventions

• DrugPrednisolone

  Prednisolone 2.7 mg daily

• Drugdipyridamole

  dipyridamole 360 mg daily

• DrugPrednisone

  Prednisone 5 mg daily

• DrugZ102

  Prednisolone 2.7 mg plus dipyridamole 360 mg daily

  Also known as: prednisolone, dipyridamole

• Otherplacebo

Primary outcomes

1. Change From Baseline in DAS28-CRP at 12 Weeks

   The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.

   Time frame: baseline to week 12

Secondary outcomes

1. Change From Baseline in DAS28-CRP Individual Components at 12 Weeks

   The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a high level of disease activity.

   Time frame: Baseline to week 12

2. Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks

   The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.

   Time frame: Week 12

3. Multidimensional Assessment of Fatigue (MAF) at Week 12

   The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week. To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15. Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they "do not do any activity for reasons other than fatigue." If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index.

   Time frame: week 12

4. Time to Failure (Days)

   Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.

   Time frame: Baseline to 12 weeks

Baseline characteristics