Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

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

Arthritis

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

This study's enrollment of 143 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Study arms

• Experimental
  Arm 1: Clazakizumab (Dose # A) (Double-Blind)

  Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate

  Drug: Clazakizumab

• Experimental
  Arm 2: Clazakizumab (Dose # B) (Double-Blind)

  Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate

  Drug: Clazakizumab

• Experimental
  Arm 3: Clazakizumab (Dose # C) (Double-Blind)

  Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate

  Drug: Clazakizumab

• Experimental
  Arm 4: Placebo matching with Clazakizumab (Double-Blind)

  Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate

  Drug: Placebo (Matching with Clazakizumab)

Interventions

• DrugClazakizumab

  Also known as: BMS-945429

• DrugPlacebo (Matching with Clazakizumab)

Primary outcomes

1. Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12

   DAS28-CRP describes severity of rheumatoid arthritis. The components of the joint count assessment are shoulder, elbow, wrist, metacarpophalangeal joints 1 through 5, proximal interphalangeal joints 1 through 5, and the knee joints on the right and left sides, whereby the number of affected joints, tender and swollen, respectively, are counted. The formula used to calculate the score is: DAS28-CRP=0.56 \\times \\sqrt{TEN28} + 0.28 \\times \\sqrt{SW28} + 0.36 \\times \\ln(CRP+1) + 0.014 \\times SA+0.96 with: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale between 0 and 100 ("0":no activity, "100": highest activity possible). DAS-CRP score range is 0.49 to 9.07 A DAS-CRP value \>5.1 corresponds to a high disease activity A DAS-28 reduction by 0.6 represents a moderate improvement. A reduction \>1.2 represents a major improvement

   Time frame: Baseline and Week 12

Secondary outcomes

1. American College of Rheumatology (ACR) 20/50/70 Response Rates

   The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

   Time frame: At week 12

2. Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12

   CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI \<= 2.8 = Remission CDAI \> 2.8 and \<= 10 = Low Disease Activity CDAI \> 10 and \<= 22 = Moderate Disease Activity CDAI \> 22 = High Disease Activity

   Time frame: Baseline and week 12

3. Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12

   SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity

   Time frame: Baseline and week 12

4. Boolean Remission at Week 12

   Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)

   Time frame: At week 12

5. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12

   Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.

   Time frame: Baseline and Week 12

6. Percent of Participants With a DAS28-Erythrocyte Sedimentation Rate (ESR) <2.6

   DAS28- ESR = Disease Activity Scores 28 based on erythrocyte sedimentation rate. A DAS28-ESR below 2.6 is interpreted as remission.

   Time frame: At week 12

7. Percent of Participants With a DAS28-C Reactive Protein (CRP) <2.6

   DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.

   Time frame: At week 12

Baseline characteristics

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