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To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

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ClinicalTrials.gov Identifier: NCT01160822
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : August 30, 2012
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Biological: Canakinumab
Drug: Placebo to canakinumab
Drug: Naproxen
Drug: Placebo to Naproxen

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Part A: Canakinumab 150 mg Participants received a single intra-articular injection of 150 mg canakinumab.
Part A: Canakinumab 300 mg Participants received a single intra-articular injection of 300 mg canakinumab.
Part A: Canakinumab 600 mg Participants received a single intra-articular injection of 600 mg canakinumab.
Part A: Placebo Participants received a single intra-articular injection of canakinumab-matching placebo.
Part B: Canakinumab Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Part B: Placebo Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Part B: Naproxen Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.

Participant Flow:   Overall Study
    Part A: Canakinumab 150 mg   Part A: Canakinumab 300 mg   Part A: Canakinumab 600 mg   Part A: Placebo   Part B: Canakinumab   Part B: Placebo   Part B: Naproxen
STARTED   6   7   6   5   45   47   53 
COMPLETED   6   7   6   5   36   40   44 
NOT COMPLETED   0   0   0   0   9   7   9 
Adverse Event                0                0                0                0                1                2                5 
Unsatisfactory therapeutic effect                0                0                0                0                4                5                3 
Withdrawal by Subject                0                0                0                0                0                0                1 
Lost to Follow-up                0                0                0                0                1                0                0 
Administrative problems                0                0                0                0                1                0                0 
Protocol deviation                0                0                0                0                2                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Part A: Canakinumab 150 mg Participants received a single intra-articular injection of 150 mg canakinumab.
Part A: Canakinumab 300 mg Participants received a single intra-articular injection of 300 mg canakinumab.
Part A: Canakinumab 600 mg Participants received a single intra-articular injection of 600 mg canakinumab.
Part A: Placebo Participants received a single intra-articular injection of canakinumab-matching placebo.
Part B: Canakinumab Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Part B: Placebo Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Part B: Naproxen Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Part A: Canakinumab 150 mg   Part A: Canakinumab 300 mg   Part A: Canakinumab 600 mg   Part A: Placebo   Part B: Canakinumab   Part B: Placebo   Part B: Naproxen   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   7   6   5   45   47   53   169 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 58.3  (12.79)   61.0  (9.63)   64.2  (10.68)   57.8  (7.76)   NA [1]   NA [1]   NA [1]   60.5  (10.07) 
[1] Age demographic data for Study Part A.
Age, Customized [1] 
[Units: Years]
Mean (Standard Deviation)
 NA [1]   NA [1]   NA [1]   NA [1]   61.4  (8.96)   60.3  (9.71)   62.2  (8.10)   61.3  (8.89) 
[1] Age demographic data for Study Part B.
Gender 
[Units: Participants]
               
Female   3   4   2   2   31   31   34   107 
Male   3   3   4   3   14   16   19   62 


  Outcome Measures

1.  Primary:   Part A: Number of Participants With Intolerance Events   [ Time Frame: Baseline to Day 3 ]

2.  Primary:   Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)   [ Time Frame: Baseline and Day 4 ]

3.  Primary:   Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale   [ Time Frame: Baseline and Week 4 ]

4.  Secondary:   Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)   [ Time Frame: Baseline and Weeks 4, 8 and 12 ]

5.  Secondary:   Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)   [ Time Frame: Baseline, Day 4, Weeks 1, 2, 4, 8 and 12 ]

6.  Secondary:   Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales   [ Time Frame: Baseline and Weeks 4, 8 and 12 ]

7.  Secondary:   Part B: Proportion of Participants Who Used Rescue Analgesic During Study   [ Time Frame: Day 4, Weeks 1, 2, 4, 8 and 12 ]

8.  Secondary:   Patient’s Global Assessment of Response to Treatment on Day 4   [ Time Frame: Day 4 ]

9.  Secondary:   Patient's Global Assessment of Response to Treatment at Week 2   [ Time Frame: Week 2 ]

10.  Secondary:   Patient's Global Assessment of Response to Treatment at Week 4   [ Time Frame: Week 4 ]

11.  Secondary:   Patient's Global Assessment of Response to Treatment at Week 8   [ Time Frame: Week 8 ]

12.  Secondary:   Patient's Global Assessment of Response to Treatment at Week 12   [ Time Frame: Week 12 ]

13.  Secondary:   Part B: Physician's Global Assessment of Response to Treatment at Day 4   [ Time Frame: Day 4 ]

14.  Secondary:   Part B: Physician's Global Assessment of Response to Treatment at Week 2   [ Time Frame: Week 2 ]

15.  Secondary:   Part B: Physician's Global Assessment of Response to Treatment at Week 4   [ Time Frame: Week 4 ]

16.  Secondary:   Part B: Physician's Global Assessment of Response to Treatment at Week 8   [ Time Frame: Week 8 ]

17.  Secondary:   Part B: Physician's Global Assessment of Response to Treatment at Week 12   [ Time Frame: Week 12 ]

18.  Secondary:   Maximum Observed Plasma Concentration of Canakinumab (Cmax)   [ Time Frame: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126. ]

19.  Secondary:   Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)   [ Time Frame: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126. ]

20.  Secondary:   Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)   [ Time Frame: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126. ]

21.  Secondary:   Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)   [ Time Frame: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126. ]

22.  Secondary:   Terminal Phase Half-life (t1/2) of Canakinumab   [ Time Frame: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126. ]

23.  Secondary:   Apparent Clearance of Canakinumab From Plasma (CL/F)   [ Time Frame: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126. ]

24.  Secondary:   Apparent Volume of Distribution During Terminal Phase (Vz/F)   [ Time Frame: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01160822     History of Changes
Other Study ID Numbers: CACZ885C2201
2009-015017-48 ( EudraCT Number )
First Submitted: July 9, 2010
First Posted: July 12, 2010
Results First Submitted: July 26, 2012
Results First Posted: August 30, 2012
Last Update Posted: October 30, 2012