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Trial record 49 of 1664 for:    ( Map: Bulgaria )

A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis (PRIORA)

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ClinicalTrials.gov Identifier: NCT01317797
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: namilumab (MT203)
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 10 investigative sites in Bulgaria, Netherlands and Spain from 09 March 2011 to 08 August 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of mild or moderate rheumatoid arthritis were enrolled into 1 of 3 treatment groups namilumab (MT203) 150mg, namilumab 300 mg or placebo.

Reporting Groups
  Description
Namilumab 150 mg Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab 300 mg Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Placebo Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.

Participant Flow:   Overall Study
    Namilumab 150 mg   Namilumab 300 mg   Placebo
STARTED   8   7   9 
COMPLETED   8   6   8 
NOT COMPLETED   0   1   1 
Other                0                1                0 
Withdrawal of Patient                0                0                1 



  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
Namilumab 150 mg Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab 300 mg Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Placebo Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Total Total of all reporting groups

Baseline Measures
   Namilumab 150 mg   Namilumab 300 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   7   9   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.0  (6.95)   56.6  (15.28)   53.4  (11.05)   55.9  (11.05) 
Gender 
[Units: Participants]
       
Female   5   6   6   17 
Male   3   1   3   7 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   7   7   9   23 
Black   1   0   0   1 
Height 
[Units: Cm]
Mean (Standard Deviation)
 166.21  (8.605)   168.57  (6.321)   168.44  (5.126)   167.74  (6.581) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 68.13  (7.140)   80.44  (7.305)   77.80  (8.617)   75.35  (9.147) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.69  (2.471)   28.30  (1.778)   27.37  (2.246)   26.75  (2.607) 
Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 4.70  (0.542)   4.66  (0.544)   4.60  (0.512)   4.65  (0.510) 
[1] The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst).


  Outcome Measures

1.  Primary:   Number of Participants With Clinically Significant Clinical Laboratory Results   [ Time Frame: From Day 1 Up to Day 118 ]

2.  Primary:   Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings   [ Time Frame: From Day 1 Up to Day 118 ]

3.  Primary:   Number of Participants With Clinically Significant Vital Signs   [ Time Frame: From Day 1 Up to Day 118 ]

4.  Primary:   Number of Participants With Clinically Significant Pulmonary Function Tests   [ Time Frame: From Day 1 Up to Day 118 ]

5.  Primary:   Number of Participants With Clinically Significant Physical Examination Findings   [ Time Frame: From Day 1 Up to Day 118 ]

6.  Primary:   Number of Participants Reporting One or More Treatment Emergent Adverse Events   [ Time Frame: From Day 1 Up to Day 118 ]

7.  Secondary:   Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203   [ Time Frame: Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) ]

8.  Secondary:   Cmax: Maximum Observed Plasma Concentration for MT203   [ Time Frame: Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) ]

9.  Secondary:   AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203   [ Time Frame: Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) ]

10.  Secondary:   AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203   [ Time Frame: Day 29 (Pre-dose and 2 and 6 hours post-dose) ]

11.  Secondary:   AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203   [ Time Frame: Day 29 (Pre-dose and 2 and 6 hours post-dose) ]

12.  Secondary:   Terminal Phase Elimination Half-life (T1/2) for MT203   [ Time Frame: Day 29 (Pre-dose and 2 and 6 hours post-dose) ]

13.  Secondary:   Ctrough: Maximum Observed Plasma Concentration Pre-Dose   [ Time Frame: Days 1, 15 and 29 Pre-dose ]

14.  Secondary:   Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma   [ Time Frame: Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118 ]

15.  Secondary:   Change From Baseline in MT203/GM-CSF Complexes in Plasma   [ Time Frame: Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118 ]

16.  Secondary:   Number of Participants With Anti-MT203 Antibodies   [ Time Frame: From Day 1 Up to Day 118 ]

17.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR 20) Response   [ Time Frame: Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118 ]

18.  Secondary:   Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)   [ Time Frame: Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118 ]


  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: Medical Director, Clinical Science
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01317797     History of Changes
Other Study ID Numbers: M1-1188-002-EM
2010-018502-36 ( EudraCT Number )
U1111-1137-3923 ( Registry Identifier: WHO )
NL33507.058.10 ( Registry Identifier: CCMO )
First Submitted: February 18, 2011
First Posted: March 17, 2011
Results First Submitted: July 24, 2015
Results First Posted: August 20, 2015
Last Update Posted: August 20, 2015