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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 
Overall Participants Analyzed 
[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 (77.55%)   117/138 (84.78%)   172/195 (88.21%) 
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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