A Phase 2 interventional study of Adalimumab and Placebo for adalimumab in Crohn's Disease, sponsored by AbbVie. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 30 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
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Exclusion Criteria:
Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
Biological: Adalimumab · Biological: Placebo for adalimumab
Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
Biological: Adalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection.
Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.
Mean Serum Adalimumab Concentration at Week 8
Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.
Time frame: Week 8
Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab
The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value for each parameter.
Time frame: 26 weeks
Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab
The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.
Time frame: From Week 0 to Week 26
Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab
Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively.
Time frame: 26 weeks
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below.
Time frame: 35 weeks
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Time frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Time frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
CDAI: Mean Change From Baseline to Each Visit
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26
hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26
Fecal Calprotectin: Change From Baseline (Week 0) to Week 8
Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.
Time frame: Baseline (Week 0) and Weeks 4 and 8
Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8
Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations \>2 μg/mL.
Time frame: Baseline (Week 0) to Week 8
| Milestone | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Started | 15 | 15 |
| Completed double-blind period | 14 | 14 |
| Entered open-label extension period | 13 | 14 |
| Completed | 11 | 11 |
| Not completed | 4 | 4 |
| Withdrew: Adverse event | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.
| μg/mL | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Mean Serum Adalimumab Concentration at Week 8 | 7.99 ± 3.48 | 10.0 ± 4.57 |
The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value for each parameter.
| participants | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Haemoglobin <80 g/L (n=15,15) | 1 | 1 |
| White Blood Cells ≥1 x10^9/L (n=15,15) | 1 | 0 |
| Neutrophils <1.0x10^9/mcL (n=15,15) | 1 | 0 |
| Lymphocytes <0.5x10^3/mcL (n=15,13) | 2 | 0 |
The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.
| participants | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Potassium <3.0 mmol/L | 0 | 1 |
| Sodium <130 mmol/L | 0 | 1 |
| Albumin <20 g/L | 0 | 1 |
| Calcium <1.75 mmol/L | 0 | 1 |
| Uric Acid >500µmol/L | 0 | 1 |
Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively.
| participants | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| SBP ≤90 mm Hg or ≥20 mm Hg ↓ from BL | 7 | 5 |
| SBP ≥180 mm Hg or ≥20 mm Hg ↑ from BL | 8 | 3 |
| DBP ≤50 mm Hg or ≥15 mm Hg ↓ from BL | 3 | 4 |
| SBP ≥105 mm Hg or ≥15 mm Hg ↑ from BL | 6 | 4 |
| Pulse ≤50 bpm or ≥15 bpm ↓ from BL | 6 | 7 |
| Pulse SBP ≥120 bpm or ≥15 bpm ↑ from BL | 7 | 6 |
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below.
| participants | Low Induction Dose (Double-blind Period) | Standard Induction Dose (Double-blind Period) | Low Induction Dose (Open-label Extension Period) | Standard Induction Dose (Open-label Extension) |
|---|---|---|---|---|
| Any TEAE | 6 | 7 | 7 | 7 |
| Any TESAE | 1 | 1 | 1 | 2 |
| TEAE leading to discontinuation | 2 | 1 | 1 | 2 |
| Severe TEAE | 0 | 1 | 0 | 1 |
| TEAEs with reasonable possibility of being related | 3 | 6 | 5 | 6 |
| Deaths | 0 | 0 | 0 | 0 |
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
| percentage of participants | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Week 2 | 26.7 (7.8 to 55.1) | 46.7 (21.3 to 73.4) |
| Week 4 | 40.0 (16.3 to 67.7) | 66.7 (38.4 to 88.2) |
| Week 6 | 60.0 (32.3 to 83.7) | 73.3 (44.9 to 92.2) |
| Week 8 | 60.0 (32.3 to 83.7) | 66.7 (38.4 to 88.2) |
| Week 10 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
| Week 12 | 60.0 (32.3 to 83.7) | 73.3 (44.9 to 92.2) |
| Week 14 | 60.0 (32.3 to 83.7) | 73.3 (44.9 to 92.2) |
| Week 16 | 60.0 (32.3 to 83.7) | 73.3 (44.9 to 92.2) |
| Week 18 | 60.0 (32.3 to 83.7) | 73.3 (44.9 to 92.2) |
| Week 20 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
| Week 22 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
| Week 24 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
| Week 26 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
| percentage of participants | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Week 2 | 66.7 (38.4 to 88.2) | 80.0 (51.9 to 95.7) |
| Week 4 | 93.3 (68.1 to 99.8) | 93.3 (68.1 to 99.8) |
| Week 6 | 93.3 (68.1 to 99.8) | 86.7 (59.5 to 98.3) |
| Week 8 | 93.3 (68.1 to 99.8) | 86.7 (59.5 to 98.3) |
| Week 10 | 86.7 (59.5 to 98.3) | 86.7 (59.5 to 98.3) |
| Week 12 | 80.0 (51.9 to 95.7) | 80.0 (51.9 to 95.7) |
| Week 14 | 73.7 (44.9 to 92.2) | 73.7 (44.9 to 92.2) |
| Week 16 | 80.0 (51.9 to 95.7) | 73.7 (44.9 to 92.2) |
| Week 18 | 80.0 (51.9 to 95.7) | 73.7 (44.9 to 92.2) |
| Week 20 | 73.7 (44.9 to 92.2) | 66.7 (38.4 to 88.2) |
| Week 22 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
| Week 24 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
| Week 26 | 66.7 (38.4 to 88.2) | 66.7 (38.4 to 88.2) |
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.
| units on a scale | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Week 2 | -108.91 ± 76.196 | -143.79 ± 86.193 |
| Week 4 | -152.96 ± 71.589 | -163.21 ± 95.545 |
| Week 6 | -163.53 ± 80.868 | -178.23 ± 103.159 |
| Week 8 | -181.50 ± 81.611 | -181.87 ± 100.077 |
| Week 10 | -185.24 ± 81.532 | -182.87 ± 96.039 |
| Week 12 | -200.33 ± 88.612 | -191.09 ± 98.035 |
| Week 14 | -193.63 ± 97.130 | -194.96 ± 111.444 |
| Week 16 | -198.07 ± 96.381 | -191.37 ± 108.932 |
| Week 18 | -200.17 ± 93.758 | -188.31 ± 109.516 |
| Week 20 | -214.43 ± 96.417 | -189.83 ± 110.845 |
| Week 22 | -213.95 ± 98.357 | -194.53 ± 111.046 |
| Week 24 | -215.47 ± 99.278 | -187.98 ± 107.702 |
| Week 26 | -215.79 ± 101.879 | -200.17 ± 110.999 |
hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.
| mg/L | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Week 1 | -7.70 (-74.8 to 28.1) | -24.51 (-187.6 to -1.7) |
| Week 2 | -14.10 (-83.3 to 32.3) | -25.37 (-184.7 to 5.3) |
| Week 4 | -12.05 (-93.2 to 42.2) | -21.12 (-170.6 to 43.0) |
| Week 6 | -12.66 (-94.6 to 46.2) | -21.61 (-165.9 to 18.2) |
| Week 8 | -11.90 (-98.9 to 13.0) | -21.58 (-165.1 to 12.9) |
| Week 12 | -9.40 (-114.9 to 17.6) | -15.00 (-188.3 to 50.5) |
| Week 16 | -14.00 (-101.1 to 0.8) | -15.10 (-191.1 to 33.7) |
| Week 20 | -9.50 (-108.5 to 0.1) | -12.80 (-194.2 to 21.5) |
| Week 24 | -12.90 (-112.4 to 13.7) | -12.90 (-194.6 to 32.5) |
| Week 26 | -11.20 (-103.4 to 16.8) | -6.90 (-194.6 to 22.5) |
Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.
| μg/g | Low Induction Dose | Standard Induction Dose |
|---|---|---|
| Week 4 | -135.0 (-1441 to 3397) | -207.0 (-1334 to 3410) |
| Week 8 | -44.0 (-1926 to 5632) | -274.0 (-915 to 6213) |
Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations \>2 μg/mL.
No measurements were reported for this outcome.
Collected over Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 35 weeks); SAEs were collected from the time informed consent was obtained (39 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Induction Dose (Double-blind) | — | 1/15 (6.7%) | 6/15 (40%) |
| Standard Induction Dose (Double-blind) | — | 1/15 (6.7%) | 7/15 (46.7%) |
| Low Induction Dose (Open-label Extension) | — | 1/13 (7.7%) | 6/13 (46.2%) |
| Standard Induction Dose (Open-label Extension) | — | 2/14 (14.3%) | 6/14 (42.9%) |
| Event | Low Induction Dose (Double-blind) | Standard Induction Dose (Double-blind) | Low Induction Dose (Open-label Extension) | Standard Induction Dose (Open-label Extension) |
|---|---|---|---|---|
| CROHN'S DISEASEGastrointestinal disorders | 1/15 | 1/15 | 0/13 | 2/14 |
| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVEInvestigations | 0/15 | 0/15 | 1/13 | 0/14 |
| INTESTINAL OBSTRUCTIONGastrointestinal disorders | 0/15 | 1/15 | 0/13 | 0/14 |
| LUNG INFECTIONInfections and infestations | 0/15 | 1/15 | 0/13 | 0/14 |
| TUBERCULOSIS GASTROINTESTINALInfections and infestations | 0/15 | 1/15 | 0/13 | 0/14 |
| Event | Low Induction Dose (Double-blind) | Standard Induction Dose (Double-blind) | Low Induction Dose (Open-label Extension) | Standard Induction Dose (Open-label Extension) |
|---|---|---|---|---|
| LEUKOPENIABlood and lymphatic system disorders | 3/15 | 1/15 | 2/13 | 1/14 |
| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVEInvestigations | 0/15 | 0/15 | 0/13 | 2/14 |
| PYREXIAGeneral disorders | 2/15 | 1/15 | 0/13 | 1/14 |
| ALANINE AMINOTRANSFERASE INCREASEDInvestigations | 0/15 | 2/15 | 0/13 | 0/14 |
| ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations | 0/15 | 2/15 | 0/13 | 1/14 |
| APHTHOUS STOMATITISGastrointestinal disorders | 0/15 | 0/15 | 1/13 | 0/14 |
| GASTROENTERITISInfections and infestations | 0/15 | 0/15 | 1/13 | 0/14 |
| PHARYNGITISInfections and infestations | 0/15 | 0/15 | 1/13 | 0/14 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 0/15 | 0/15 | 1/13 | 0/14 |
| ANIMAL BITEInjury, poisoning and procedural complications | 0/15 | 0/15 | 1/13 | 0/14 |
| Age, Continuous(years) | Low Induction Dose | Standard Induction Dose | Total |
|---|---|---|---|
| Mean | 33.5 ± 14.60 | 35.6 ± 13.00 | 34.5 ± 13.63 |
| Sex: Female, Male(Participants) | Low Induction Dose | Standard Induction Dose | Total |
|---|---|---|---|
| Female | 2 | 4 | 6 |
| Male | 13 | 11 | 24 |
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