A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-Naive - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition:	Rheumatoid Arthritis
Interventions:	Biological: golimumab Drug: placebo; methotrexate Drug: golimumab; methotrexate Biological: Golimumab

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a multicenter, randomized, double-blind, placebo-controlled, 4-arm, parallel-group study with the first patient consented on 12Dec2005. The Week 24 database lock was 01 Oct. 2007. 637 subjects were randomized at 90 centers: 25 sites in Asia, 34 sites in Europe/Australia/New Zealand, 10 sites in Latin America and 21 sites in North America.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Group I: Placebo + Methotrexate (MTX)	Placebo SC injections every 4 wks from Wk 0 to Wk 48 (unless early escape at Wk 28); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 50 mg SC injection every 4 wks from Wk 28 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group II: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injection every 4 wks from Wk 0 for up to 5 yrs, placebo capsule MTX weekly from Wk 0 to unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked) unless early escape at Wk 28; MTX - If early escape start 10 mg weekly during blinded period; MTX - Dr's discretion, adjust weekly dose after unblinding.
Group III: Golimumab 50 mg + Methotrexate (MTX)	Golimumab 50 mg SC injections every 4 wks from Wk 0-48 (Wk 28 if early escape); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 100 mg beginning at Wk 28 for up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group IV: Golimumab 100 mg + Methotrexate (MTX)	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; MTX - 10 to 20 mg from Wk 0 for up to 5 years.

Participant Flow: Overall Study

	Group I: Placebo + Methotrexate (MTX)	Group II: Golimumab 100 mg + Placebo	Group III: Golimumab 50 mg + Methotrexate (MTX)	Group IV: Golimumab 100 mg + Methotrexate (MTX)
STARTED	160	159	159	159
COMPLETED	150^[1]	150^[2]	151^[3]	149^[4]
NOT COMPLETED	10	9	8	10
Adverse Event	1	1	5	6
Unsatisfactory theapeutic effect	1	3	0	0
Lost to Follow-up	3	0	1	1
Death	0	0	1	1
Patient relocated	1	0	0	0
Not specified	4	5	1	2

[1]	Indicates number of patients that are continuing subcutaneous study agent at Week 24
[2]	Indicates number of patients that are continuing subcutaneous study agent at Week 24
[3]	Indicates number of patients that are continuing subcutaneous study agent at Week 24
[4]	Indicates number of patients that are continuing subcutaneous study agent at Week 24

Baseline Characteristics

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Reporting Groups

	Description
Group I: Placebo + Methotrexate (MTX)	Placebo SC injections every 4 wks from Wk 0 to Wk 48 (unless early escape at Wk 28); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 50 mg SC injection every 4 wks from Wk 28 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group II: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injection every 4 wks from Wk 0 for up to 5 yrs, placebo capsule MTX weekly from Wk 0 to unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked) unless early escape at Wk 28; MTX - If early escape start 10 mg weekly during blinded period; MTX - Dr's discretion, adjust weekly dose after unblinding.
Group III: Golimumab 50 mg + Methotrexate (MTX)	Golimumab 50 mg SC injections every 4 wks from Wk 0-48 (Wk 28 if early escape); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 100 mg beginning at Wk 28 for up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group IV: Golimumab 100 mg + Methotrexate (MTX)	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; MTX - 10 to 20 mg from Wk 0 for up to 5 years.

Baseline Measures

	Group I: Placebo + Methotrexate (MTX)	Group II: Golimumab 100 mg + Placebo	Group III: Golimumab 50 mg + Methotrexate (MTX)	Group IV: Golimumab 100 mg + Methotrexate (MTX)	Total
Number of Participants [units: participants]	160	159	159	159	637
Age [units: years] Mean ± Standard Deviation	48.6 ± 12.91	48.2 ± 12.85	50.9 ± 11.32	50.2 ± 11.87	49.5 ± 12.28
Gender [units: participants]
Female	134	134	135	125	528
Male	26	25	24	34	109

Outcome Measures

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1. Primary:

American College of Rheumatology 50 Response at Week 24 [ Week 24 ]

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2. Secondary:

American College of Rheumatology 20 Response at Week 24 [ Week 24 ]

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3. Secondary:

American College of Rheumatology 50 Response at Week 24 in Patients With Abnormal C-reactive Protein at Baseline [ Week 24 ]

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Serious Adverse Events

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Additional Description	No text entered.

Reporting Groups

	Description
Group I: Placebo + Methotrexate (MTX)	Placebo SC injections every 4 wks from Wk 0 to Wk 48 (unless early escape at Wk 28); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 50 mg SC injection every 4 wks from Wk 28 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group II: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injection every 4 wks from Wk 0 for up to 5 yrs, placebo capsule MTX weekly from Wk 0 to unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked) unless early escape at Wk 28; MTX - If early escape start 10 mg weekly during blinded period; MTX - Dr's discretion, adjust weekly dose after unblinding.
Group III: Golimumab 50 mg + Methotrexate (MTX)	Golimumab 50 mg SC injections every 4 wks from Wk 0-48 (Wk 28 if early escape); MTX - 10 to 20 mg from Wk 0 for up to 5 years; golimumab - If early escape, 100 mg beginning at Wk 28 for up to 5 yrs; golimumab - Dr's discretion after unblinding (last patients enrolled completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
Group IV: Golimumab 100 mg + Methotrexate (MTX)	Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; MTX - 10 to 20 mg from Wk 0 for up to 5 years.

Serious Adverse Events

	Group I: Placebo + Methotrexate (MTX)	Group II: Golimumab 100 mg + Placebo	Group III: Golimumab 50 mg + Methotrexate (MTX)	Group IV: Golimumab 100 mg + Methotrexate (MTX)
Total, serious adverse events
# participants affected	11	5	10	10
Blood and lymphatic system disorders
Anaemia ^†^A # participants affected / at risk	1/160 (0.63%)	2/157 (1.27%)	0/158 (0.00%)	0/159 (0.00%)
Cardiac disorders
Cardio-respiratory arrest ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Myocardial infarction ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Congenital, familial and genetic disorders
Spondylolisthesis ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Gastrointestinal disorders
Abdominal pain ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Colitis ischaemic ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Duodenal ulcer ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Abdominal adhesions ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Rectal haemorrhage ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
General disorders
Pyrexia ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Hepatobiliary disorders
Hepatomegaly ^†^A # participants affected / at risk	0/160 (0.00%)	1/157 (0.64%)	0/158 (0.00%)	0/159 (0.00%)
Infections and infestations
Pneumonia ^†^A # participants affected / at risk	1/160 (0.63%)	1/157 (0.64%)	0/158 (0.00%)	2/159 (1.26%)
Abscess ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Arthritis bacterial ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Bone tuberculosis ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Bursitis infective ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Enteritis infectious ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Gastroenteritis ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Pelvic inflammatory disease ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Upper respiratory tract infection ^†^A # participants affected / at risk	0/160 (0.00%)	1/157 (0.64%)	0/158 (0.00%)	1/159 (0.63%)
Salpingitis ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Sepsis ^†^A # participants affected / at risk	0/160 (0.00%)	1/157 (0.64%)	0/158 (0.00%)	0/159 (0.00%)
Urinary tract infection ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Injury, poisoning and procedural complications
Facial bones fracture ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Scapula fracture ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis ^†^A # participants affected / at risk	1/160 (0.63%)	1/157 (0.64%)	0/158 (0.00%)	0/159 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Hodgkin's disease ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Breast cancer ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Lip neoplasm malignant stage unspecified ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Nervous system disorders
Hypoglycaemic coma ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Vocal cord paralysis ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Psychiatric disorders
Completed suicide ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Major depression ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Reproductive system and breast disorders
Polycystic ovaries ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)
Respiratory, thoracic and mediastinal disorders
Alveolitis fibrosing ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Interstitial lung disease ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Pneumonitis ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	1/159 (0.63%)
Skin and subcutaneous tissue disorders
Panniculitis ^†^A # participants affected / at risk	0/160 (0.00%)	0/157 (0.00%)	1/158 (0.63%)	0/159 (0.00%)
Rash ^†^A # participants affected / at risk	1/160 (0.63%)	0/157 (0.00%)	0/158 (0.00%)	0/159 (0.00%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10.0

Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

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
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.

Results Point of Contact:

Name/Title: Director Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399

No publications provided

Responsible Party:	Centocor Inc. ( Director of Clinical Research )
Study ID Numbers:	CR006331, C0524T05, GO-BEFORE
Study First Received:	December 11, 2005
Results First Received:	May 21, 2009
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00264537 History of Changes
Health Authority:	United States: Food and Drug Administration