Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00634933 |
Recruitment Status :
Terminated
(The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.)
First Posted : March 13, 2008
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
|
Sponsor:
Pfizer
Collaborator:
Trubion Pharmaceuticals/Emergent BioSolutions Inc.
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Arthritis, Rheumatoid |
Interventions |
Drug: TRU-015 Drug: Methylprednisolone Drug: Prednisone |
Enrollment | 222 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose | Placebo/TRU-015 Single Dose | Placebo/TRU-015 Induction Dose |
---|---|---|---|---|---|
![]() |
Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study. | TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36. | TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36. | TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36. | TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36. |
Period Title: Part A: Baseline to Week 24 | |||||
Started | 74 | 75 | 73 | 0 | 0 |
Completed | 63 | 57 | 55 | 0 | 0 |
Not Completed | 11 | 18 | 18 | 0 | 0 |
Reason Not Completed | |||||
Adverse Event | 4 | 4 | 8 | 0 | 0 |
Death | 1 | 0 | 0 | 0 | 0 |
Failed to Return | 1 | 0 | 0 | 0 | 0 |
Investigator Request | 1 | 1 | 1 | 0 | 0 |
Lost to Follow-up | 0 | 1 | 1 | 0 | 0 |
Withdrawal by Subject | 0 | 3 | 3 | 0 | 0 |
Lack of Efficacy | 3 | 1 | 0 | 0 | 0 |
Other | 1 | 8 | 5 | 0 | 0 |
Period Title: Between Part A and Part B | |||||
Started | 0 | 57 | 55 | 31 | 32 |
Completed | 0 | 56 | 55 | 31 | 32 |
Not Completed | 0 | 1 | 0 | 0 | 0 |
Reason Not Completed | |||||
Physician Decision | 0 | 1 | 0 | 0 | 0 |
Period Title: Part B: Week 24 to Week 52 | |||||
Started | 0 | 56 | 55 | 31 | 32 |
Completed | 0 | 42 | 33 | 25 | 22 |
Not Completed | 0 | 14 | 22 | 6 | 10 |
Reason Not Completed | |||||
Adverse Event | 0 | 1 | 1 | 1 | 0 |
Discontinuation of Study by Sponsor | 0 | 11 | 14 | 3 | 7 |
Physician Decision | 0 | 1 | 1 | 0 | 0 |
Protocol Violation | 0 | 0 | 0 | 0 | 1 |
Withdrawal by Subject | 0 | 0 | 0 | 2 | 1 |
Lack of Efficacy | 0 | 1 | 1 | 0 | 0 |
Other | 0 | 0 | 5 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Placebo | TRU-015 Single Dose | TRU-015 Induction Dose | Total | |
---|---|---|---|---|---|
![]() |
Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36. | TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36. | TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36. | Total of all reporting groups | |
Overall Number of Baseline Participants | 74 | 75 | 73 | 222 | |
![]() |
[Not Specified]
|
||||
Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||
Number Analyzed | 74 participants | 75 participants | 73 participants | 222 participants | |
50.62 (11.07) | 52.99 (11.33) | 52.55 (13.00) | 52.05 (11.81) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 74 participants | 75 participants | 73 participants | 222 participants | |
Female |
64 86.5%
|
62 82.7%
|
59 80.8%
|
185 83.3%
|
|
Male |
10 13.5%
|
13 17.3%
|
14 19.2%
|
37 16.7%
|
Outcome Measures
Adverse Events
Limitations and Caveats
As the results of the primary analysis did not meet the predefined efficacy criteria, the development of TRU-015 was discontinued.
More Information
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00634933 |
Obsolete Identifiers: | NCT01616706 |
Other Study ID Numbers: |
3206K1-2203 B2051001 |
First Submitted: | March 5, 2008 |
First Posted: | March 13, 2008 |
Results First Submitted: | December 27, 2012 |
Results First Posted: | March 11, 2013 |
Last Update Posted: | March 11, 2013 |