A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00299546
First received: March 3, 2006
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Placebo
Biological: Golimumab 50 mg
Biological: Golimumab 100 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 461 participants were enrolled at 86 sites in North America, Europe, Australia and New Zealand.

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
Group 1: Placebo Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.

Participant Flow:   Overall Study
    Group 1: Placebo     Group 2: Golimumab 50 mg     Group 3: Golimumab 100 mg  
STARTED     155     153     153  
COMPLETED     55     61     67  
NOT COMPLETED     100     92     86  
Death                 3                 2                 0  
Lost to Follow-up                 2                 2                 5  
Adverse Event                 37                 22                 27  
Unsatisfactory therapeutic effect                 34                 39                 34  
Not specified                 24                 26                 19  
Not treated                 0                 1                 1  



  Baseline Characteristics
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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
Group 1: Placebo Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
Total Total of all reporting groups

Baseline Measures
    Group 1: Placebo     Group 2: Golimumab 50 mg     Group 3: Golimumab 100 mg     Total  
Number of Participants  
[units: participants]
  155     153     153     461  
Age  
[units: years]
Mean ± Standard Deviation
  54.8  ± 13.07     53.9  ± 11.47     53.7  ± 12.26     54.1  ± 12.27  
Gender  
[units: participants]
       
Female     132     113     122     367  
Male     23     40     31     94  



  Outcome Measures
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1.  Primary:   American College of Rheumatology (ACR) 20 Response at Week 14.   [ Time Frame: Week 14 ]

2.  Secondary:   American College of Rheumatology (ACR) 50 Response at Week 14   [ Time Frame: Week 14 ]

3.  Secondary:   Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14   [ Time Frame: Week 14 ]

4.  Secondary:   American College of Rheumatology (ACR) 20 at Week 24   [ Time Frame: From Baseline to Week 24 ]

5.  Secondary:   Health Assessment Questionnaire (HAQ) Score at Week 24   [ Time Frame: From Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Adverse event data were collected for 5 years
Additional Description Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Group 1: Golimumab 50 mg SC Injections Only Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
Group 2: Golimumab 100 mg SC Injections Only Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
Group 3: Golimumab 50 and 100 mg SC Injections Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.

Other Adverse Events
    Group 1: Golimumab 50 mg SC Injections Only     Group 2: Golimumab 100 mg SC Injections Only     Group 3: Golimumab 50 and 100 mg SC Injections  
Total, other (not including serious) adverse events        
# participants affected / at risk     76/98     117/138     172/195  
Ear and labyrinth disorders        
Vertigo † 1      
# participants affected / at risk     5/98 (5.10%)     4/138 (2.90%)     4/195 (2.05%)  
Eye disorders        
Dry Eye † 1      
# participants affected / at risk     5/98 (5.10%)     4/138 (2.90%)     5/195 (2.56%)  
Gastrointestinal disorders        
Diarrhoea † 1      
# participants affected / at risk     4/98 (4.08%)     22/138 (15.94%)     28/195 (14.36%)  
Gastrooesophageal Reflux Disease † 1      
# participants affected / at risk     1/98 (1.02%)     6/138 (4.35%)     10/195 (5.13%)  
Nausea † 1      
# participants affected / at risk     9/98 (9.18%)     18/138 (13.04%)     21/195 (10.77%)  
Vomiting † 1      
# participants affected / at risk     3/98 (3.06%)     12/138 (8.70%)     7/195 (3.59%)  
General disorders        
Fatigue † 1      
# participants affected / at risk     2/98 (2.04%)     16/138 (11.59%)     16/195 (8.21%)  
Injection Site Erythema † 1      
# participants affected / at risk     6/98 (6.12%)     13/138 (9.42%)     18/195 (9.23%)  
Oedema Peripheral † 1      
# participants affected / at risk     3/98 (3.06%)     10/138 (7.25%)     11/195 (5.64%)  
Pyrexia † 1      
# participants affected / at risk     2/98 (2.04%)     4/138 (2.90%)     10/195 (5.13%)  
Immune system disorders        
Seasonal Allergy † 1      
# participants affected / at risk     2/98 (2.04%)     9/138 (6.52%)     2/195 (1.03%)  
Infections and infestations        
Bronchitis † 1      
# participants affected / at risk     11/98 (11.22%)     22/138 (15.94%)     24/195 (12.31%)  
Ear Infection † 1      
# participants affected / at risk     2/98 (2.04%)     7/138 (5.07%)     8/195 (4.10%)  
Influenza † 1      
# participants affected / at risk     4/98 (4.08%)     7/138 (5.07%)     15/195 (7.69%)  
Nasopharyngitis † 1      
# participants affected / at risk     10/98 (10.20%)     26/138 (18.84%)     37/195 (18.97%)  
Oral Herpes † 1      
# participants affected / at risk     6/98 (6.12%)     9/138 (6.52%)     7/195 (3.59%)  
Pneumonia † 1      
# participants affected / at risk     2/98 (2.04%)     7/138 (5.07%)     6/195 (3.08%)  
Rhinitis † 1      
# participants affected / at risk     2/98 (2.04%)     9/138 (6.52%)     2/195 (1.03%)  
Sinusitis † 1      
# participants affected / at risk     19/98 (19.39%)     23/138 (16.67%)     35/195 (17.95%)  
Upper Respiratory Tract Infection † 1      
# participants affected / at risk     25/98 (25.51%)     43/138 (31.16%)     49/195 (25.13%)  
Urinary Tract Infection † 1      
# participants affected / at risk     13/98 (13.27%)     12/138 (8.70%)     22/195 (11.28%)  
Viral Infection † 1      
# participants affected / at risk     2/98 (2.04%)     7/138 (5.07%)     4/195 (2.05%)  
Injury, poisoning and procedural complications        
Contusion † 1      
# participants affected / at risk     2/98 (2.04%)     8/138 (5.80%)     12/195 (6.15%)  
Excoriation † 1      
# participants affected / at risk     3/98 (3.06%)     6/138 (4.35%)     10/195 (5.13%)  
Laceration † 1      
# participants affected / at risk     2/98 (2.04%)     7/138 (5.07%)     14/195 (7.18%)  
Investigations        
Alanine Aminotransferase Increased † 1      
# participants affected / at risk     6/98 (6.12%)     0/138 (0.00%)     5/195 (2.56%)  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     12/98 (12.24%)     20/138 (14.49%)     25/195 (12.82%)  
Back Pain † 1      
# participants affected / at risk     8/98 (8.16%)     17/138 (12.32%)     36/195 (18.46%)  
Bursitis † 1      
# participants affected / at risk     4/98 (4.08%)     6/138 (4.35%)     10/195 (5.13%)  
Joint Swelling † 1      
# participants affected / at risk     1/98 (1.02%)     8/138 (5.80%)     3/195 (1.54%)  
Muscle Spasms † 1      
# participants affected / at risk     1/98 (1.02%)     12/138 (8.70%)     6/195 (3.08%)  
Musculoskeletal Pain † 1      
# participants affected / at risk     2/98 (2.04%)     9/138 (6.52%)     15/195 (7.69%)  
Osteoarthritis † 1      
# participants affected / at risk     3/98 (3.06%)     5/138 (3.62%)     13/195 (6.67%)  
Pain in Extremity † 1      
# participants affected / at risk     4/98 (4.08%)     9/138 (6.52%)     16/195 (8.21%)  
Rheumatoid Arthritis † 1      
# participants affected / at risk     14/98 (14.29%)     23/138 (16.67%)     53/195 (27.18%)  
Tendonitis † 1      
# participants affected / at risk     4/98 (4.08%)     12/138 (8.70%)     16/195 (8.21%)  
Nervous system disorders        
Dizziness † 1      
# participants affected / at risk     4/98 (4.08%)     8/138 (5.80%)     10/195 (5.13%)  
Headache † 1      
# participants affected / at risk     14/98 (14.29%)     14/138 (10.14%)     19/195 (9.74%)  
Hypoaesthesia † 1      
# participants affected / at risk     2/98 (2.04%)     8/138 (5.80%)     5/195 (2.56%)  
Paraesthesia † 1      
# participants affected / at risk     4/98 (4.08%)     8/138 (5.80%)     11/195 (5.64%)  
Psychiatric disorders        
Anxiety † 1      
# participants affected / at risk     1/98 (1.02%)     12/138 (8.70%)     11/195 (5.64%)  
Depression † 1      
# participants affected / at risk     3/98 (3.06%)     8/138 (5.80%)     18/195 (9.23%)  
Insomnia † 1      
# participants affected / at risk     0/98 (0.00%)     11/138 (7.97%)     11/195 (5.64%)  
Respiratory, thoracic and mediastinal disorders        
Cough † 1      
# participants affected / at risk     10/98 (10.20%)     13/138 (9.42%)     24/195 (12.31%)  
Oropharyngeal Pain † 1      
# participants affected / at risk     4/98 (4.08%)     8/138 (5.80%)     15/195 (7.69%)  
Skin and subcutaneous tissue disorders        
Rash † 1      
# participants affected / at risk     4/98 (4.08%)     8/138 (5.80%)     19/195 (9.74%)  
Vascular disorders        
Hypertension † 1      
# participants affected / at risk     10/98 (10.20%)     17/138 (12.32%)     34/195 (17.44%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA Version 15.0



  Limitations and Caveats
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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
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.


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